Senior Specialist Pharmacovigilance (Maternity Leave Cover)

Job Description The Senior Pharmacovigilance (PV) Specialist is responsible for executing assigned local PV activities independently and ensuring full compliance with applicable regulations, company policies, and procedures. The role supports day-to-day pharmacovigilance operations across one or more countries, working closely with internal teams and external partners to maintain patient safety, regulatory compliance, and high-quality safety data.

As required by local PV legislation and business needs, the Senior PV Specialist may also be designated as the back-up local Qualified Person for PV (QPPV), back-up Local PV Contact, or back-up Local Responsible PV Person. In the absence of the PV Lead, the role may manage day-to-day PV activities under appropriate supervision. Key Responsibilities: Local Pharmacovigilance Operations Execute local PV processes and activities in collaboration with internal functions and external partners.

Ensure activities are aligned with local legislation and regional/global company procedures. Support management and negotiation of local PV agreements. Conduct local due diligence activities. Support implementation of Post-Approval Safety Monitoring Programs (PSMPs). Coordinate aggregate safety report submissions. Conduct local PV training and support communication of safety issues. Review local initiatives for compliance with PV requirements.

Adverse Event Case Management Manage day-to-day adverse event processing activities. Perform case intake, translations, acknowledgments, follow-up, and submission in line with PV procedures and country regulations. Compliance, Quality, and Inspection Readiness Support local PV, business partner, and vendor audits and inspections. Contribute to inspection readiness and development of CAPAs for findings and observations.

Participate in issue management and compliance activities, including local corrective actions. Conduct or support PV self-inspections where applicable. Support implementation of business continuity plans. File, store, and archive safety-related documentation according to company and local requirements. Documentation and Procedural Support Assist in developing and maintaining local PV procedures and controlled documents.

Maintain documentation such as SOPs, training materials, and controlled PV documents, including the Company Core Pharmacovigilance Document where applicable. Coordinate or complete translations of PV documents and ensure QC review by a second person where required. Risk Management and Safety Surveillance Prepare, maintain, and submit local Risk Management Plans (RMPs) where applicable. Ensure implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally.

Manage and perform local literature screening and assessment as required. Monitor Health Authority websites for safety alerts, emerging safety issues, and updated PV requirements where applicable. Cross-functional Collaboration Liaise with local business units to provide updates on safety activities and support strategic decisions. Represent PV in cross-functional forums and alliance partner meetings as needed.

Participate in local committees and councils impacting PV. Engage in external industry forums and interactions with regulatory authorities where applicable. Leadership and Development May manage direct reports, including recruitment, training, development, and performance management. Support PV Lead with maintenance of the local PV training matrix and onboarding plans. Participate in special projects or rotational assignments within or outside IPV for professional development.

Complete all required training on time and before performing assigned activities. Qualifications: Degree in health, life sciences, or medical sciences, or equivalent through education/experience. Minimum 2 years of experience in the pharmaceutical industry preferred. Supervisory experience preferred if the role includes management of staff. Strong knowle