Pharmacovigilance Case Processing Officer

About the role

Servier Monde is seeking a Pharmacovigilance Case Processing Officer to manage outsourced safety cases from collection through regulatory submission. The role ensures that all activities performed by external vendors meet internal quality standards and global regulatory requirements.

Key responsibilities

• Oversee pre‑ and post‑marketing pharmacovigilance cases processed by a service provider, including booking, data entry, coding, narrative writing, quality control, medical review and submission.
• Perform weekly quality checks on vendor‑processed cases and draft deviation forms, root‑cause analyses and CAPAs for late submissions.
• Review clinical trial protocols and eCRFs, write Safety Management Plans and request updates to ARGUS configurations.
• Coordinate with local pharmacovigilance teams, business partners and clinical databases, and act as a Subject Matter Expert during audits and inspections.
• Contribute to process optimisation, author quality documents and validate vendor invoices.

Required profile

• Healthcare or scientific degree (Pharmacy, Medicine, Life Sciences or equivalent).
• Minimum 4 years of experience in pharmacovigilance case management within an international environment.

Required skills

• Strong knowledge of global pharmacovigilance regulatory requirements and Safety Data Exchange Agreements.
• Proficiency with pharmacovigilance databases, especially ARGUS, and the MS Office suite.
• Experience in literature surveillance, quality control, CAPA drafting and KPI definition.
• Fluent written and spoken English.
• Ability to set up and review performance indicators for outsourced activities.