Pharmacovigilance manager

A Pharmacovigilance Manager oversees a company's drug safety monitoring programs, ensuring compliance with global and local regulations and company policies. Key responsibilities include managing adverse event reporting, conducting risk assessments, detecting safety signals, overseeing vendor management, preparing safety reports, and collaborating with cross-functional teams and regulatory bodies to safeguard public health. Strong leadership, a deep understanding of pharmacovigilance regulations, and excellent communication skills are crucial for success in this role.

Key Responsibilities

Drug Safety Monitoring:

Manage the overall safety profile of new and marketed drugs, monitoring for and investigating adverse events.

Regulatory Compliance:

Ensure the pharmacovigilance system and operations comply with all applicable local, national, and international regulations and guidelines, such as those from NAFDAC.

Reporting & Risk Management:

Oversee the collection, review, and analysis of safety data, prepare and submit periodic safety reports (e.g., PSURs) and other regulatory documents, and conduct benefit-risk assessments.

Signal Detection:

Lead activities to detect, assess, and prevent potential adverse drug reactions or other safety issues.

Vendor & Partner Oversight:

Manage outsourcing vendors and partners, ensuring their compliance with contracts and regulatory standards.

Process Development:

Develop, review, and update Standard Operating Procedures (SOPs) and internal processes for pharmacovigilance.