Summary
Overview
Work History
Education
Skills
Languages
Additional Information
Work Availability
Timeline
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Behdokht Alinaghian

Behdokht Alinaghian

Adelaide,SA

Summary

Skilled in medical affairs with over 10 years of diverse expertise in healthcare and pharmaceuticals. Proficient in efficiently managing regulatory processes, monitoring drug safety, and facilitating medical product registration with Intercultural skilled. Keen eye for detail with a passion for continuous improvement, developing risk management plans and ensuring compliance.

Overview

16
16
years of professional experience

Work History

Senior Pharmacovigilance Specialist

Institute Of Pharmacovigilance
04.2022 - Current
  • Support inspections audit as well as CAPAs management.
  • Evaluate safety profiles, signal detection reports, monitor document filing and archiving.
  • Conduct case reconciliation with internal departments, distributors, affiliates and business partners.
  • Review, comply and analyze data for safety database management.
  • Train staff and update training documents to meet pharmacovigilance regulations.

Successfully extended pharmacovigilance regulation into international markets. Efficiently managed more than 7 audits and inspections, consistently achieving positive outcomes with zero major findings. My comprehensive training program resulted in a notable reduction in error rates.

Regulatory Affairs Officer

Pharmaceutical Multinational's Subsidiary
10.2014 - 10.2022
  • Effectively managed and enhanced dossiers pertaining to pharmaceutical and medical equipment products, ensuring compliance with regulatory guidelines, and implementing strategies when necessary.
  • Point of contact between organization, multinational manufacturer companies, stakeholders and regulatory authorities.
  • Responded to inquiries, audits, and inspections, Supported Quality Assurance as required.
  • Initiated communication with healthcare professionals to assess their needs, collaborated with marketing team to successfully promote products and services.

Registered more than 20 new medical device products and more than 10 new drug molecules as unique treatments to the Iranian Drug list and social security insurance coverage (Ministry of Health) from creditable multinational companies (Novartis, Bayer, Novo Nordisk, Boehringer, Gilead, ConvaTec, Nutritia, Eli Lilly, Alcon , BioMarin, Desitine).

Hospital Pharmacist

Tehran University Of Medical Sciences
10.2012 - 10.2014
  • Collaborated with healthcare professionals in clinical settings to optimize treatment protocols and involved in hospital accreditation program.
  • As preceptor, provided clinical, practice-based instruction to medical students at clinical practice sites.
  • provided TPN (Total Parental Nutrition) as method of feeding nutritional formula intravenously, bypassing usual process of eating and digestion.

As a pioneering hospital pharmacist and the supervisor of the Pharmaceutical Care Department at the hospital, I led the implementation of new strategy for medication management and patient pharmaceutical consultations, which conducted as research projects with healthcare teams, resulting in more than 20% improvement in therapeutic outcomes for patients.

Clinical Medicine Specialist

National Drug And Poisoning Information Centre
09.2010 - 10.2014
  • Counseled patients and health care professional as part of medical canter's 24-hour on-call services related to pharmaceutical care.
  • Trained medical students and in using medical devices and software in accordance with drug policy and regulatory guidelines.

As the owner of the top online consultancy service specializing in patient surveys in 2012 and 2013, I successfully introduced the DPIC Centre to the community through a series of interviews with reputable Iranian journals.

Research Assistant

Tehran University Of Medical Science
02.2008 - 01.2012
  • Conducted research into various methodologies for preparation, loading, and characterization of Nanoliposomes.
  • Conducted research on protective effect of Glycopeptide on rat's hepatocytes.
  • Utilized range of analytical software and sample analysis techniques to generate comprehensive and professional reports.

Prepared and characterized of Nanoliposomes co‐encapsulating Doxorubicin and Fluoxetine to overcome MDR. (10% improvement)

Education

Master of Business Administration -

University of Tehran
Iran
03.2018

Doctor of Medicine -

Shahid Beheshti University of Medical Sciences
Iran
01.2012

Skills

  • Microsoft Office
  • Training
  • Regulatory Affairs
  • Risk Management
  • Clinical Development
  • Pharmaceutical industry
  • Pharmacovigilance
  • Analytical Skills
  • Drug safety
  • Research
  • Team Management
  • Communication

Languages

English
Full Professional
Persian
Native or Bilingual

Additional Information

Further career history: Available upon request.

Residency status: Permanent Resident in Australia.

Notice period: Immediately available.

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline

Senior Pharmacovigilance Specialist

Institute Of Pharmacovigilance
04.2022 - Current

Regulatory Affairs Officer

Pharmaceutical Multinational's Subsidiary
10.2014 - 10.2022

Hospital Pharmacist

Tehran University Of Medical Sciences
10.2012 - 10.2014

Clinical Medicine Specialist

National Drug And Poisoning Information Centre
09.2010 - 10.2014

Research Assistant

Tehran University Of Medical Science
02.2008 - 01.2012

Master of Business Administration -

University of Tehran

Doctor of Medicine -

Shahid Beheshti University of Medical Sciences
Behdokht Alinaghian