Supervisor, Pharmacovigilance
Job Location: Chennai, India
Work Model: Office with Flex (Hybrid)
Job Type: Full-Time
Job Requisition ID: JR143504
Industry: Pharmacovigilance / Drug Safety / Clinical Research
The Supervisor, Pharmacovigilance is a senior-level drug safety leadership role responsible for overseeing adverse event reporting, regulatory submissions, and pharmacovigilance operations across clinical trials and post-marketing programs. This position plays a critical role in ensuring global regulatory compliance, patient safety, and high-quality safety data management.
This opportunity is ideal for experienced pharmacovigilance professionals with strong team management capabilities and in-depth knowledge of global safety reporting requirements.
Role Overview
The Supervisor, Pharmacovigilance manages day-to-day safety operations, ensuring timely processing, review, and submission of Individual Case Safety Reports (ICSRs) and aggregate reports to regulatory authorities. The role involves cross-functional collaboration with Clinical Operations, Regulatory Affairs, Medical Safety, and Data Management teams to maintain compliance with global pharmacovigilance regulations.
The position also focuses on quality oversight, workflow optimization, and team leadership within drug safety operations.
Key Responsibilities
Supervise daily pharmacovigilance safety reporting activities, ensuring timely and accurate submissions to global regulatory authorities
Oversee case processing workflows, including ICSR intake, medical review coordination, coding, and submission
Ensure compliance with global pharmacovigilance regulations, including ICH guidelines and local health authority requirements
Manage safety submission timelines for clinical trials and post-marketing surveillance programs
Collaborate with cross-functional teams to improve safety reporting processes and operational efficiency
Monitor key performance indicators (KPIs) related to case processing and regulatory submissions
Support audit and inspection readiness activities
Provide leadership, mentorship, and performance guidance to pharmacovigilance team members
Ensure adherence to internal SOPs and quality management standards
Required Experience
Minimum 8 years of experience in pharmacovigilance or drug safety operations
Proven experience in managing safety reporting for clinical trials and/or post-marketing products
Demonstrated team management or supervisory experience
Strong background in ICSR processing and regulatory submissions
Educational Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or related healthcare field
Advanced degree preferred
Core Competencies and Skills
Strong knowledge of global pharmacovigilance regulations, including ICH, GVP, and regional reporting requirements
Experience with safety databases and pharmacovigilance systems
Leadership and team management capabilities
Excellent communication and stakeholder management skills
Strong attention to detail and commitment to data accuracy
Ability to manage multiple priorities in a deadline-driven environment
Understanding of signal detection, risk management, and safety compliance frameworks
Strategic Importance of the Role
The Supervisor, Pharmacovigilance plays a crucial role in safeguarding patient safety and maintaining regulatory compliance. Effective safety oversight directly supports product lifecycle management, regulatory approvals, and global market access.
Why Apply Through ThePharmaDaily.com
ThePharmaDaily.com connects pharmacovigilance and drug safety professionals with leading global CROs, pharmaceutical companies, and biotech organizations. If you are seeking career growth in pharmacovigilance leadership, regulatory compliance, and global safety operations, this role offers strong advancement potential.
Apply now to progress your career in Pharmacovigilance Supervision and Global Drug Safety Management.
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