Senior Manager - Pharmacovigilance

Brief Job Description

The incumbent will be responsible for managing Pharmacovigilance operations, including pharmacovigilance IT projects, Safety Data Exchange Agreements (SDEAs), targeted follow-up activities, ICSR case processing, regulatory compliance, process improvements, audits and inspections, training and development, and procedural document management. The role requires strong leadership, stakeholder management, and expertise in global pharmacovigilance regulations to ensure patient safety and compliance with applicable regulatory requirements.

Key Responsibilities

1 Pharmacovigilance IT Projects and Special Assignments

• Lead and coordinate Pharmacovigilance IT projects as Program Manager
• Collaborate with cross-functional teams to ensure successful implementation of PV systems and enhancements.
• Monitor project timelines, deliverables, risks, and stakeholder expectations.
• Drive special projects and strategic initiatives within Pharmacovigilance.

2 SDEA Management

• Coordinate with Regional Pharmacovigilance Personnel (RPPs) and internal/external stakeholders for the execution, review, and maintenance of Safety Data Exchange Agreements (SDEAs).
• Draft, review, update, and negotiate SDEAs as required.
• Ensure timely completion and compliance of SDEAs across Regions I to VII.
• Maintain tracking and oversight of agreement obligations and timelines.

3 Targeted Follow-up Activities & Twenty Minutes Training (TMT)

• Manage and monitor targeted follow-up activities in line with Risk Management Plan (RMP) commitments
• Coordinate monthly follow-up activities and ensure compliance with timelines.
• Prepare, publish, and monitor the monthly TMT calendar.
• Facilitate training sessions and track participation and effectiveness.

4 ADR Case Processing & Regulatory Compliance

• Manage ICSR case processing activities for Sun Pharma and associated company streams.
• Ensure timely and high-quality case intake, validity assessment, data entry, medical coding, and quality review activities.
• Monitor compliance with global regulatory reporting timelines.
• Drive quality metrics and continuous process improvements while ensuring regulatory compliance.
• Support workload planning, resource allocation, and performance monitoring of case processing teams.

5 Process Improvement & Innovation

• Identify opportunities for automation, digitalization, and process optimization.
• Introduce innovative solutions and tools to enhance operational efficiency and compliance.
• Lead continuous improvement initiatives and monitor effectiveness through defined KPIs.
• Benchmark industry best practices and implement relevant improvements.

6 Training & People Development

• Conduct and attend training programs as per the annual training plan.
• Mentor and coach team members to enhance technical and functional competencies.
• Support succession planning and capability development initiatives.
• Foster a culture of learning, collaboration, and continuous improvement.

7 Pharmacovigilance Audits & Inspections

• Ensure continuous audit and inspection readiness for assigned portfolios.
• Support internal, client, and regulatory audits/inspections.
• Conduct internal compliance reviews and identify improvement opportunities.
• Track audit observations, CAPAs, and ensure timely closure.

8 Management of Procedural Documents

• Prepare, review, revise, and maintain SOPs, Work Practice Documents (WPDs), Guidelines, and associated documentation.
• Ensure procedural documents remain aligned with regulatory requirements and organizational processes.
• Facilitate stakeholder discussions and review meetings for document development and updates.
• Support document control and training on revised procedures.

Educational Qualifications

• Bachelor's Degree in Pharmacy (B.Pharm), Pharm.D, Life Sciences, Nursing, or related healthcare discipline.
• Master's Degree in Pharmacy, Life Sciences, Clinical Research, or related field preferred.

Experience

• 15+ years of experience in Pharmacovigilance Operations.
• Experience in ICSR processing, safety compliance, SDEA management, audits/inspections, and global PV regulations.
• Proven experience in team management, project management, and stakeholder engagement.