Sr. Pharmacovigilance Med Safety Officer

Sr. Pharmacovigilance Med. Safety Officer

Responsibilities

Safety Oversight & Compliance

• Support regional and local safety operations across countries within scope.
• Contribute to the maintenance and ongoing compliance of Pharmacovigilance System Master Files (PSMFs) and related documentation.
• Review safety processes and documentation to ensure alignment with global and local regulatory requirements.
• Identify, document, and support the investigation of non-conformances, working with cross-functional teams to implement effective Corrective and Preventive Actions (CAPAs).
• Prepare and present regular updates on local and regional vigilance activities to governance committees and stakeholders.

Safety Management & Reporting

• Support responses to health authority requests and safety-related enquiries.
• Perform reconciliations with distributors, vendors, third parties, and internal business functions to ensure complete and accurate safety reporting.
• Maintain oversight of literature surveillance activities and adverse event identification processes. 4. Manage document control and archiving activities in accordance with company procedures and regulatory requirements.
• Support training and awareness programs related to safety reporting responsibilities.
• Monitor regulatory developments and assess potential impacts on vigilance processes.
• Coordinate and support safety submissions and reporting activities, including serious adverse events, periodic safety reports, risk management plans, and other required submissions.
• Collaborate with regional and global teams regarding signal management, emerging safety issues, and regulatory communications.
• Support the establishment, maintenance, and review of pharmacovigilance and vigilance-related agreements.
• Assist with translations of safety-related documentation where required.

Regulatory Vigilance

• Maintain current knowledge of pharmacovigilance, cosmetovigilance, materiovigilance, and nutrivigilance requirements across relevant territories.
• Support implementation of regulatory changes impacting vigilance activities and reporting obligations.
• Ensure vigilance processes remain compliant with evolving local and international regulations.

Cross-Functional Collaboration

• Participate in global and regional projects, providing subject matter expertise on safety and vigilance processes.
• Partner closely with Medical Safety, Regulatory Affairs, Quality, Supply Chain, and external stakeholders to ensure effective execution of safety activities.
• Contribute to continuous improvement initiatives and operational excellence programs.

Quality, Audits & Inspections

• Develop, maintain, and update local procedures and work instructions in line with global standards.
• Support internal audits, inspections, and health authority interactions.
• Ensure inspection readiness and compliance with internal quality systems.