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Are you a pharmacovigilance professional looking for your next big career opportunity in Mumbai?
Syneos Health, a global leader in biopharmaceutical solutions, is hiring a Safety PV Specialist II / Principal PV Specialist on an 11-month contract. This role offers a chance to work on cutting-edge drug safety and regulatory compliance processes while contributing to life-changing therapies worldwide.
Key Responsibilities
As a Safety PV Specialist II, you will:
- Assist Clinical Safety Heads in collecting and reporting ADRs/AEs and other safety information.
- Manage Periodic Safety Reports (PSRs) in compliance with local and global PV requirements.
- Support Patient Programs (PP) and Managed Access Programs (MAP) with vendor training, QC, and reconciliation.
- Participate in due diligence and integration processes for in-licensing and acquisitions.
- Implement and maintain local SDEAs (Safety Data Exchange Agreements).
- Conduct PV awareness and refresher trainings for internal and vendor teams.
- Handle product safety alerts and recalls as per company standards.
- Develop and maintain the Local Pharmacovigilance System File (LPSF).
Qualifications
- Minimum 4 years of pharmacovigilance experience.
- Strong knowledge of regulatory PV requirements and safety reporting systems.
- Experience in PSR management, SDEA compliance, and vendor oversight.
- Candidates from Mumbai preferred.
- Immediate joiners strongly encouraged to apply.
Why Join Syneos Health?
- Be part of a global organization operating in 110+ countries.
- Exposure to industry-leading pharmacovigilance systems.
- Work with a company that supported 94% of all FDA-approved novel drugs in the past five years.
- Gain hands-on experience in clinical development and drug safety operations.
Contract Details
- Type: 11-month fixed-term contract
- Location: Mumbai, India
- Employment Type: Full-time
- Salary Range: ₹8,00,000 – ₹12,00,000 per annum (contract basis, experience-dependent)
How to Apply
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