Purnima Bhargaw

• Enter information into PVG quality and tracking systems for ICSR receipt and tracking
• Assist in preparing the Safety Management Plan
• Process ICSRs following SOPs and project-specific safety plans
• Triage and evaluate ICSR data for completeness, accuracy, and regulatory compliance
• Code events, medical history, concomitant medications, and tests
• Compile complete narrative summaries
• Assess information for queries, follow up until resolution
• Generate timely and accurate expedited reports in accordance with regulatory requirements
• Coordinate with data management staff for safety data reconciliation between clinical and safety databases
• Ensure distribution of required individual expedited and periodic reports for clinical and post-marketing projects to the Safety Submissions team if responsible for submissions
• Participate in audits and inspections as required.

● Process ICSRs of all case types (spontaneous, clinical studies, and solicited programs) according to Standard Operating Procedures which includes:

o Triage ICSRs to determine whether they qualify for expedited reporting or not and evaluate for completeness, accuracy and regulatory report ability.

o Data entry of safety events in the internal database, including determining the expectedness of adverse events against various labelling documents (such as SPC, CDS, IB etc.), writing case summaries, assessing causalities if required and writing company comment if required.

o Data validation i.e., cross checking against source emails and documentation.

● Experienced in MedDRA coding of events, medical history and tests in accordance with “MedDRA Term Selection: Points to Consider”.

● Responsible for data entry of Vaccine and Literature Individual case safety reports into the safety database (ARGUS). Review and evaluate Adverse Event (AE) case information to determine required action based on and following internal policies and procedures

● Subject Matter Expert (SME) handling client and associate queries, taking quality huddle and CAPA discussion sessions

● Experienced in compiling medically cohesive narrative summaries based upon the reported information

● Participate in audits as required.

● Handling correction requests from client and performing internal Quality Check of the cases

● Responsible for distribution of individual and periodic reports to Safety Submission teams for clinical projects.

● Supporting activities required for source data verification.

● Conducting follow-ups from initial reports and filling necessary gaps.

● Team Leader Responsibilities:

o Providing training and mentoring to Drug Safety Associate in processing of ICSRs and monitoring the compliance by monitoring the standardized ICSR lateness reasons and associated Corrective and Preventive Action (CAPA) plans.

o Team handling, conducting meetings and preparing presentation on regular basis and additional training for providing the updates to team members.

o Set clear team goals and oversee day-to-day operations.

o Listen to team members’ feedback and solve issues.

o Suggest and organize team building activities.

● Literature training:

o Experienced in review and validity assessment of literature abstracts and full articles, identifying events for coding, query identification and tracking.

● Quality control of case reports, line listings and tabulations.

● Experienced in handling the Enterprise Resource Planning (ERP) tool.

● Identifying areas of concern to the team and safely raising issues with the Team Lead.

● Maintaining an awareness of global regularity requirements and reporting obligations.

● Mentoring new recruits, as required.

● Query Management:

o Experienced in interacting with client personnel to resolve issues related to the processing of ICSRs in accordance with clients’ policies.

o Experienced in responding to clients/customers in a timely manner.

● Maintaining a good working knowledge of the Adverse Event safety profile of assigned drugs/class of drugs, Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations including:

o International Council for Harmonization of Technical Requirements (ICH) guidelines on safety and efficacy

o Good Clinical Practice Food and Drug Administration (FDA) guidelines

o The Council for International Organizations of Medical Sciences (CIOMS)

o New European Union pharmacovigilance (EU PV) legislation

o Good pharmacovigilance practices (GVP) Guidelines

● Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.

● Maintaining an awareness of performance metrics measured by client and strive to remain within established limits.