Are you an experienced pharmacovigilance professional looking for your next big career move? Syneos Health, a global leader in biopharmaceutical solutions, is inviting applications for the role of Safety PV Specialist II/Principal PV Specialist. This is an 8-month contract role based in Mumbai and is perfect for candidates with 4+ years of PV experience who are ready to make an impact.
✅ Key Responsibilities
As a Safety PV Specialist, you will:
- Assist in collection and reporting of ADRs/AEs and other safety-related information.
- Manage Periodic Safety Reports (PSR) in compliance with SOPs and local regulatory requirements.
- Support Patient Programs (PP) and Managed Access Programs (MAP) through document validation, training, and reconciliation activities.
- Participate in local product in-licensing, acquisitions, and safety due diligence processes.
- Ensure implementation and monitoring of Safety Data Exchange Agreements (SDEA).
- Conduct PV training, audits, and awareness sessions for vendors and internal teams.
- Handle Product Recalls, Safety Alerts, and Local PV Alerts in collaboration with global teams.
- Maintain the Local Pharmacovigilance System File (LPSF) as per global and local standards.
🎓 Qualifications
- Minimum 4 years of relevant pharmacovigilance experience.
- Preferred location: Mumbai.
- Strong knowledge of PSRs, PP/MAP management, SDEAs, and regulatory compliance.
- Immediate joiners will be given preference.
🌟 Why Join Syneos Health?
At Syneos Health, your work matters everywhere. The company offers:
- Global exposure across 29,000 employees and 110 countries.
- Supportive work culture with a focus on career development & training.
- Opportunity to contribute to FDA and EMA approved drugs.
- A collaborative and diverse work environment.
📌 Application Process
