Summary
Overview
Work History
Education
Skills
Accomplishments
Personal Information
On Job Training Projects
Timeline
Generic

Manpreet Pathania

Williams Landing,Australia

Summary

Quality & Compliance focused; detail-oriented; agile and inquisitive mind set with ability to work in fast-paced environment; decision-making and problem-solving skills; manage and work prioritization and multi-tasking; time management and on-time delivery of tasks; resilience with ‘Never Give-In’ attitude; team player as well as capable of working on individual projects; always ready for challenges and step-up to take additional responsibilities; strategic planning on projects.

Overview

18
18
years of professional experience

Work History

Manager, Global PV Agreements & Alliances

CSL Behring, CSL LTD
02.2023 - Current
  • Management of Pharmacovigilance Agreements (PVAs) and Pharmacovigilance (PV) Language: Manage the overall lifecycle (decision making using risk based approach, timely preparation, support Safety Officers with negotiation queries, signatures, termination/revision) of PVAs and PV Language for CSL Business partners to ensure compliance with CSL standards/processes and international PV legislation, when delegating PV activities to business Partners (In-licensed partners, Distributors, ODCS Service providers etc) and perform high-level oversight on all PV relevant business relationships on the development, maintenance and termination of all PV relevant contracts.
  • Compliance Management: Maintain and improve the global PVA System to achieve compliance according to legal pharmacovigilance requirements and internal company standards and processes. Report compliance metrics/ Key Performance Indicators (KPI’s) monthly in the Pharmacovigilance System Compliance Report and implement Corrective and Preventative Actions in case compliance is not met.
  • Alliances Management: Liaise with relevant global and local interface functions (IPV/Regions, QPPV, Legal, Commercial, Medical Affairs, PVRQA etc) for cross-functional collaboration and update and information sharing. Support QPPV office with PSMF annexes by generating the annex and ensuring the data in the annex is accurate. Provide guidance to cover specific pharmacovigilance requirements (e.g. according to results of initial due diligence, vendor qualifications and audits, risk management plans, risk minimization and mitigation measures as well as national pharmacovigilance legislation) in Pharmacovigilance Agreements. Provide strategic advice and maintain close, cross-functional interaction with all functions involved in PVA preparation and maintenance. Participate in due diligence for Business partners and provide input for PV provisions to ensure the partner is capable of performing desired PV activities and comply with CSL standards/processes and PV legislation.
  • Projects/Workshops/Achievements: Management Essential Program: Completed the Management Essential Program to upskill. HaloPV Testing: Participated in testing HaloPV for PVA/PV Clause Management workflows, ICSR reconciliation schedules and develop PVA and PSMF annex relevant report. Improved the PV clause workflow in HaloPV to maximise the use of database for accuracy in data for PSMF annexes. Support in preparation of test scripts for testing the various scenarios for PVA reports. CSL Behring/CSL Seqirus/CSL Vifor Integration Workshops: Travelled to King of Prussia and Marburg for integration workshop. As Digital Media sub-stream Lead- I developed project plan to integrate the Digital Media Process for CSL, update the process to suit all business units in collaboration with ODCS team, Regions team, Legal and Corporate Communication and GPAA team by updating the procedures, creating decision trees and overall harmonise the process across businesses. All deliverables were met on/before time. GPAA 2.0 transformation: Travelled to Maidenhead for GPAA transformation workshop for simplification and harmonisation of process across business. I provided feedback on gaps, proposed pragmatic ideas on simplifying the process and worked with the team to re-model the workflow and improve GPAA procedures, created PV language drafts, prepared the GPAA roadshow for internal stakeholders and delivered face to face & via Teams, created the training slides for Safety Officers on the new process which is now also used for Safety Officer on-boarding training. I was the first one to deliver the Roadshow face to face at APAC- IPV meet in Mar-2025 and GSPV monthly meeting. I also created and SME contact list to be used by GPAA team for contacting SMEs from various functions for PVA related queries.
  • Vendor Consolidation project (Project Symphony)- I volunteered to support R & D wide vendor consolidation project. I was involved in kick off meetings and regular functional lead meetings. I reviewed the current contracts with vendors and extracted project relevant data from the contracts. I was also involved in the RFP questionnaires discussions with the partners.
  • Mentorship program- I joined this program as a mentor and so far, I have supported 2 mentees in helping them set objectives/goals and helped them navigate to the goals.
  • Appreciation from cross-function colleagues, seniors for collaboration, problem solving, agility and quick decision making to meet the short timelines to make PVA effective.
  • Vendor Management: Manage the outsourced vendor to ensure the PVA lifecycle timelines and metric are achieved in timely manner. Provide feedback on quality and assist with queries and review of PVA. Have regular meetings with the vendor for regular team updates, provide training to the vendor on any updated or new processes.
  • Audits and Inspections: Supporting the QPPV team, PV team and CSLB Affiliates in case of regulatory authority inspections or audits and ensures inspection /audit readiness in the area of responsibility. I’m the SME for audits and inspections for PVAs and train myself regularly to be inspection ready.
  • Quality Management Systems: Maintain & oversee the PVAs on Global PVA system- HaloPV, Apttus and Companion. Use Veeva Vault for revision or creation of procedural documents, raise incident/deviations. Provide guidance to ensure that CSL quality system complies with international legislations with regard to the delegation of pharmacovigilance activities to Business Partners. Maintain and improve the global PVA System to achieve compliance according to legal pharmacovigilance requirements and internal company standards and processes.
  • Process Improvements: Develop, assess, monitor and improve the PVA processes and systems ensuring global oversight at any time and to ensure periodic and ad hoc review and communication, management of interfaces and central electronic systems in close liaison with the relevant interface functions.
  • Training skills: Provide Safety Officer and non-Safety Officer on-boarding training on the PVA process to create awareness and support Systems access to users.

Pharmacovigilance (PV) Regions Senior Associate

CSL Seqirus, CSL LTD
07.2021 - 01.2023
  • In-licensed Products: Manage Pharmacovigilance Agreements (PVA) for in-licensed partners and keep an oversight on the agreements; update the business contacts in the PVAs and update COMPANION (database repository for contractual agreements); Attend the Joint Safety Compliance meetings with partners; participate in kick off meetings with new in-licensed partners for PV requirements and PV due diligence; coordinate PV training for Merck for Seqirus representatives annually. Other tasks include- TLS encryption set-up for the partners, literature surveillance, coordinating PV questionnaires, coordinating data for PSUR/PBRER requests, termination letters, regulatory intelligence, argus configuration.
  • Organised Data Collection Programs (Market Research, disease awareness, Digital Media): Competent in managing these programs from PV perspective. Laise with various cross-functions (Commercial, Legal, Medical Affairs) to ensure a PV clause in contractual agreements, vendor qualification, PV training for the vendor and reviewing the program material and contractual agreements; Provide timely PV Approval to the program initiator and send stakeholder notifications internally and to the in-licensed partners; Track the programs for record keeping; Ensure the reconciliations are initiated on time.
  • I was involved in an Investigator Initiated Research for a licensed product. I attended kick off meetings, reviewed study protocol and agreement associated with the collaborative study.
  • Monitoring/Managing inboxes: Manage all emails received in Australia LocalSafetyContact inbox (AULSC) mailbox daily and support all Seqirus products (Flu vaccines-seasonal/pandemic, PNS and In-licensed products) in Australia and New Zealand by ensuring that all the notifications, PV Agreement updates, PSUR requests, safety signals/significant safety issues related communications, Product Information updates etc, are actioned immediately within the specified timeframe and smooth flow of information between cross-functions (Regulatory Affairs, Case Management, Risk Management, Safety Physicians, Commercial Operations, Business Development, QPPVs); Perform local literature surveillance; First point of contact and representative for PV Regions in APAC Region.
  • Supporting QPPVA/PV Regions Manager/Head of Regions: Managed the setting up of shared mailbox for local QPPV; Monitor this inbox for urgent matters in the absence of QPPVA and Deputy (provided support during Christmas break); Perform the after-hours QPPV contact testing on behalf of QPPV office routinely; Support local QPPVs (Australia and New Zealand) by directing all safety signals/significant safety issues, health authority communications to them, drafting PSUR/PBRER/RMP summaries for PSUR/PBRER/RMP received from In-licensed partners; Notifying the QPPVs of any trends in product technical complaints (PTC) after reviewing the weekly PTC line listings; Drafting the Monthly LSO report for Australia and New Zealand and distributing to local QPPVs.
  • Audit & inspections: Part of audit-support in PV inspections and audits as SME; Scribe for ALK PV inspection in JUN 2022; Help with pre and post document requests and QC of documents during audit/inspection.
  • Projects/achievements: Cross function collaboration: On regular basis collaborate with our internal stakeholder- Medical affairs, Commercial Operations, Regulatory Affairs, Business Development, Legal Case Management and local QPPV in relation to PSUR data requests, updates in PI, SSI, POPs/DM etc; Worked closely with PVQA for audit requests; PV Regions representative in FIX meetings to provide updates from PV Regions, Region’s input/feedback for other department updates; chaired the meeting.
  • Integration CSL Behring and CSL Seqirus: Leading the Digital Media work stream to unify the PV processes for Digital Media as the 2 companies integrate; Support ODCS and PV agreements workstream with data migration, reviewing documents and providing input on impacts of change in processes on in-licensed products and the workflow during regular after hour meetings; Attended workshops for Project Ocean and contributed in the development of haloPV on topics including configurations of automated reconciliations, PV clauses and entering a POP/DM; Attended meetings on Seqirus interface, ODCS, PV clauses and Companion and provided input; Involved in testing reconciliations using Code beamer.
  • Support Seqirus Korea LTD set-up: Provided the QPPV and PV requirements for this project; Attended meetings to discuss operation model for the affiliate.
  • Process Improvements: Proposed updates to the POPs SOP for in-licensed products (SOP-000098225); Stepped up to update it and the associated request form (eg. Updated to added medical devices, timelines for initiating the request); Ensured all cross-functions impacted are trained on the SOP; Developed a Work Instruction for monitoring the AU local safety contact inbox; Developed In-licensed and non-MAH reporting rules matrix for in-licensed products, reconciliation schedule; Maintain the in-licensed product list for case management; Actively review procedural documents, line listings etc. internally as well for cross-functions and provide my input.
  • Workshops: PVRM collective ambition: Developed stakeholder relationships skills; Enhance my skill of on developing and maintaining the relationships going forward to have win: win outcomes. ARCS workshop- Post-Marketing obligations of medical device and IVD (sponsored and manufactured products). Efficient collaboration via discovery Insight workshops.

Pharmacovigilance (PV) Specialist

SEQIRUS (FORMERLY BIOCSL), CSL LIMITED
07.2013 - 06.2020
  • Subject Matter Expert In-Licensed Case Management: Competent with the in-licensed product profile and the PV agreements with the License partners; Train new staff on Case Management; Perform case processing in Safety database; Perform ICSR exchanges with License Partners and expedited reporting to Health Authorities; Perform reconciliations with Licensed partners, internal stake holders (Medical Information, Local Safety Contacts, PTC group); Manage all Case Management queries; Establish cross-functional relationship with internal stakeholders and provide support; Developed process improvements for in-licensed products Case Management- identified gaps in Standard Operating procedures (SOPs) and work instructions, updated the existing SOPs and developed new work instructions for reconciliation and case processing activities; Created the in-licensed tracker.
  • Audits and Inspections: PV SME for all In-Licensed partners audits for interviews, requests and CAPA management (Interviewed for ALK-Abello audit in Sep2016, Grunenthal Audit in Mar2020, UCB audit in Aug-2020, there were no critical findings); Back room support for Health Canada Inspection Nov 2018, TGA inspection in Nov2019, PEI PV inspection in Nov2019; Support the pre and post audit requests and ensure timely delivery of the requests and CAPA responses (supported audit requests, line listing QC/review for audits- FDA GMP audit, FDA Marburg audit, LSSA audit for Argentina).
  • Vendor Management: Oversight on vendor (liaise with vendor to ensure good quality data, perform and/or assist with the resolution of any issues relating to case management including case processing conventions; train and mentor staff on case processing and familiarization with safety database; Perform database testing during transition of processes to the vendors; perform weekly meetings with vendors; Perform Off-line Quality Check (QC) of case entry and provide feedback (I developed the offline QC process by creating work instructions and offline tracker for errors type/category which was easy-to-use tool to pull out all sorts of data required for metrics, created monthly metrics and presented the same to the senior management, performed weekly meetings with the vendors to discuss the errors and liaised with the vendor for any trends noticed in errors and provide refresher trainings as necessary).
  • Clinical trial activities: Proficient in case processing and unblinding the reports, expedited reporting to regulatory authority and to the sites for EC and IRB submissions; Well-versed with RAVE/EDC clinical database; Raise queries on RAVE; Perform reconciliations; Perform cross-functional information exchange between the clinical data management team and vendor for reviewing any inconsistencies in the data on RAVE or Safety database; Liaise with study sites, CROs, Risk Management, Regulatory Affairs and Clinical Data Management for Seqirus clinical studies; Presented in investigator meetings (SAE reporting process, SAE reporting plans, SAE reconciliation plan, protocol review etc); Experience in preparing the SAE reporting plan, SAE reconciliation plan, and reference cards for the trials; attend cross functional meeting as PV representative to provide PV updates.
  • Other PV activities: Monitor the Central PV inbox (for incoming cases, triage cases an ensure timely reporting of Adverse Events (AEs) to the partners and regulatory authorities, manage queries); first point of contact, liaise with internal and external stake holders for any troubleshooting; On-board training and shadowing new staff; perform weekly meetings to mentor the employees not based on-site; compliance monitoring; support cross-functions in SOPs and procedural documents review; step-up in absence of PV Manager and co-workers to ensure compliance in daily activities; confident in abiding by the company values and handling case management activities independently; Perform VEARs and TGA reconciliations of ICSRs; Resolve troubleshooting with database and liaise with Seqirus systems and systems vendor for database improvements.
  • Projects/Achievements: MHRA CAPA Project; Created the in-licensed tracker which was used to track all the in-licensed cases received by PV with date of submission to Partners, reporting to TGA and reference numbers; Database transition Project-travelled to India for workshops for workflow management, set up E2BR3 reporting to FDA (via esumitter and WebTrader) and later involved in E2BR3 testing to set up Argus 8.1; Database Testing for migration of database and E2B case reports; Developed and drove the project for setting up reporting rules for tracking of submissions to license partners and health authority on Safety database; IRMS upgrade; Appreciations by Senior Management for stepping up in challenging times and taking additional responsibilities to keep up the compliance and cross-functionally for closing DSUR data lock for a clinical trial well in time.

Employee Health and Safety Representative

CSL LTD
02.2017 - 07.2017
  • I volunteered for this role.
  • Responsible to ensure that all the major/minor incidents in the CSL campus (block 5) that I become aware of are brought to attention of the committee.
  • Perform monthly inspections of the floor, to ensure all the electrical are safe and not overdue for servicing, all the chemical (eg., cleaning detergents etc.) are not expired and safe to use, first-aid kits are well equipped and there is a safe and healthy environment for everyone.

Drug Safety Specialist

ROCHE PRODUCTS PTY LTD
05.2012 - 06.2013
  • Receive, evaluate process and report drug safety information in accordance with local and global SOPs.
  • Support to the Head of Drug Safety in oversight activities and ensure PV compliance and inspection-readiness.
  • Provide on-board training to new staff and mentoring them on database.
  • Perform reconciliation of AE reports between local clinical study databases and the global drug safety database.
  • Liaise with the doctors, nurses, pharmacist, vendors, sales team, customer service and medical information, over the phone or via emails, to get further information about the patients and adverse events.
  • Handle queries from the processing centres and global team.
  • Ensure drug safety activities were consistently completed and executed in full compliance with the company and regulatory requirements.
  • Review local scientific literature for relevant reportable AEs as per global SOPs.
  • Perform expedited reporting and submission of drug safety information to regulatory authorities.
  • Developed new and updated existing local SOPs and work instructions.
  • Case Processing project on non-interventional programs.
  • Handled PV projects on oversight on PI, PBRERS, and follow-up back log.

Chief Pharmacovigilance Scientist

QUANTUM SOLUTION INDIA (NOW PARAXEL)
04.2011 - 06.2011
  • Specialise in reporting clinical and literature cases (clinical safety reporting, also included performing searches of literature articles, initiation and coding).
  • Manage short-term project under supervision of Roche mentors/QSI team leader (managed a project on Death NOS cases).
  • Maintain awareness of global regulatory reporting obligations and organize workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
  • Prepare documentation for regulatory submissions, including aggregate reports (PSURs), in a format set by the client per the regulatory requirements.
  • Worked on projects for Roche and Sanofi Aventis with area of expertise in oncology, dermatology, haematology, respiratory medicine, endocrinology, internal medicine, infectious diseases and general medicine.

Subject Matter Expert (Triage)

QUANTUM SOLUTION INDIA (NOW PARAXEL)
10.2009 - 03.2011
  • Manage triage by preparing rosters and distribution lists for a team of 60.
  • Handle triage-related queries, create tracker to record trends of mistriages leading to inactivation, deletion, compliance etc. and give feedback to the team (through mails and personally).
  • Manage staff availability and workload for triage activities.
  • Perform single case initiation, if required (in case of literature cases only).
  • Triage the ADRAC/TGA line listing (perform initiation for cases requiring immediate attention, code then and get them medically assessed for submitting then per the regulatory timelines).

Drug Safety Associate

QUANTUM SOLUTION INDIA (NOW PARAXEL)
10.2007 - 09.2009
  • Capture and assess Single AE reports associated with Roche products on a worldwide basis on the Drug Safety database (ADVENT), in accordance with International and local regulatory requirements.
  • Ensure clear and accurate data capture of adverse event cases (including serious and non-serious cases from spontaneous or solicited origin and serious cases from clinical trial origin) and appropriate medical assessment (including company causality and labeling) of single AE reports in accordance with Roche conventions/guidelines and Standard Operating Procedures.
  • Experience on assessing serious adverse events cases from ADRAC (now TGA), Australia for Roche.

Trainee, Quality Assurance

SURYA PHARMACEUTICALS
08.2007 - 10.2007
  • Handle HPLC (Nucon 5765, Perkinelmer clarus 500) and Gas Chromatography to check for impurities and sign quality assurance certificate for products.
  • Handle SOPs and quality assurance of the drug manufactured by the company.

Education

Master of Biotechnology -

D.A.V College
01.2007

Bachelor of Science - Biotechnology

G.G.D.S.D College
01.2005

Senior Secondary Examination - Medical

The Lawrence School Sanawar
01.2002

High School - undefined

St. Mary’s Convent School
01.2000

Skills

  • Collaborative and good communication skills
  • AI automation tools
  • MS office
  • Outlook
  • SharePoint
  • Trackwise
  • Process Improvements
  • Quality Management Systems
  • Regulatory Authority portals
  • C-language
  • Bioinformatics
  • Compliance Management
  • Regulatory Compliance
  • Vendor Management
  • Risk assessment
  • Training and presentation skills
  • Contract negotiation
  • Contract management
  • Key Performance Indicators
  • Performance management
  • Leadership mentoring
  • Pharmacovigilance management
  • Guidelines on Good Pharmacovigilance Practices
  • Pharmacovigilance regulations
  • Biotechnology
  • Microbiology
  • DNA/RNA extractions
  • Microbial cultures
  • Blood cultures
  • Sampling
  • PCR techniques
  • Laboratory experience
  • Preparation of bacterial cultures
  • Handling microscopes
  • Perform polymerase chain reaction
  • Chromatographic techniques

Accomplishments

  • Received proficiency in Biology for securing highest marks in Biology in Class XII board examination
  • Received proficiency certificate of merit award for playing chess (Year XII)
  • Played basketball, badminton, chess and athletics at school level and secured 2nd position in 4x400mtrs relay at Annual Athletics Meet (Year XII)
  • Got Bronze medal in Panjab Inter-College Chess Championship for the session 2004-05 (B.Sc 3rd year)

Personal Information

  • Father's Name: Mr. Inderjit Singh
  • Mother's Name: Mrs. Surinder Kaur
  • Husband's Name: Mr. Maninder Singh Pathania

On Job Training Projects

  • Industrial training on research project entitled, “Chemical and Microbiological Characteristics of Effluent Discharges”, CENTRAL RESEARCH INSTITUTE, Kasauli, India, 2006-06-01
  • Industrial training on research project entitled, “Microbiological and Biochemical Analysis of Water Samples”, G.G.D.S.D COLLEGE, DEPARTMENT OF BIOTECHNOLOGY, Chandigarh, India, 2005-03-01
  • Industrial training on research project was entitled, “The Study of Micro flora on Clinical and Healthcare Settings”, FORTIS HEART AND MULTI-SPECIALTY, Mohali, India, 2004-06-01
  • Industrial training on research project entitled, “Isolation and Identification of Bacteria and Extraction of Plasmids”, CENTRAL RESEARCH INSTITUTE, Kasauli, India, 2003-06-01

Timeline

Manager, Global PV Agreements & Alliances

CSL Behring, CSL LTD
02.2023 - Current

Pharmacovigilance (PV) Regions Senior Associate

CSL Seqirus, CSL LTD
07.2021 - 01.2023

Employee Health and Safety Representative

CSL LTD
02.2017 - 07.2017

Pharmacovigilance (PV) Specialist

SEQIRUS (FORMERLY BIOCSL), CSL LIMITED
07.2013 - 06.2020

Drug Safety Specialist

ROCHE PRODUCTS PTY LTD
05.2012 - 06.2013

Chief Pharmacovigilance Scientist

QUANTUM SOLUTION INDIA (NOW PARAXEL)
04.2011 - 06.2011

Subject Matter Expert (Triage)

QUANTUM SOLUTION INDIA (NOW PARAXEL)
10.2009 - 03.2011

Drug Safety Associate

QUANTUM SOLUTION INDIA (NOW PARAXEL)
10.2007 - 09.2009

Trainee, Quality Assurance

SURYA PHARMACEUTICALS
08.2007 - 10.2007

Bachelor of Science - Biotechnology

G.G.D.S.D College

Senior Secondary Examination - Medical

The Lawrence School Sanawar

High School - undefined

St. Mary’s Convent School

Master of Biotechnology -

D.A.V College

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Manpreet Pathania