Servier is looking for a PV Specialist to play a key role in our drug safety and pharmacovigilance efforts. In this position, you will develop Risk Management Plans and conduct Individual Case Safety Report processing, ensuring compliance with regulations and optimizing processes with vendors and stakeholders to maximize the value of our products.
What You'll Do
- Prepare and revise drug Risk Management Plans by investigating development and competitive product information.
- Describe Safety Specifications, Pharmacovigilance activities, and Risk minimization activities within Risk Management Plans.
- Interact with regulatory authorities (e.g., PMDA) concerning RMPs and related matters, including responding to inquiries.
- Maintain Risk Management Plans as the lead preparer, collaborating with internal and external stakeholders such as Global Safety, R&D, PMS, and Medical teams.
- Plan and conduct Early Post-Marketing Phase Vigilance (EPPV) in collaboration with the Pharmacovigilance operational and Sales departments.
- Conduct ICSR processing with domestic CROs and vendors, collaborating with Global safety-ICSR and tool teams.
- Troubleshoot ICSR processing within the Argus/J system.
- Write, submit, and manage periodic safety reports (e.g., DSUR, PSUR) and reexamination application dossiers, tracking their progress.
- Communicate with regulatory authorities concerning periodic safety reports and reexamination applications.
- Draft and implement safety assurance measures.
- Review Drug Safety-related documents, including CTD for new drug applications and materials for ensuring proper use.
- Respond to inspections and audits by domestic and overseas regulatory authorities and internal departments.
What We're Looking For
- A university or graduate degree in Medicine, Pharmaceutical Sciences, or Natural Sciences with a specialty/master's degree.
- Native Japanese proficiency and business-level fluency in English.
- Ability to give presentations and exchange emails in English.
- Excellent reading comprehension of English documents in medical and pharmaceutical sciences (e.g., Common Technical Documents), with a TOEIC L/R score of 750 or above.
- Minimum 5 years of work experience in pharmacovigilance for drug development or post-marketing.
- Experience managing product PV risk with other departments, partners, HQs, CROs, and/or regulatory authorities.
- Experience in charge of ICSR processing within pharmaceutical companies or CROs.
- Experience preparing various periodic reports (e.g., DSUR, J-PSUR, Periodic Report for Non-Serious Unlisted Adverse Drug Reactions).
- Experience preparing risk management plans.
Nice to Have
- Medical qualifications.
Technical Stack
- Argus/J
Servier is an equal opportunity employer.
