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Pharmacovigilance Operations Manager
Il y a 33 minutes
PV Case Processing Manager
- Responsable des opérations en pharmacovigilance
- Responsable opérationnel de la pharmacovigilance
Location: Greater Paris area (hybrid working model)
Sector: Global Pharmaceutical / Life Sciences
Employment Type: Permanent
The Opportunity
We are supporting a well-established, research-driven pharmaceutical organisation with a strong global footprint in the appointment of a PV Case Processing Manager. This is a critical replacement hire within a growing global safety organisation, operating across both clinical development and post-marketing activities.
The role sits at the heart of global pharmacovigilance operations and will play a key part in ensuring business continuity, regulatory compliance, and high-quality case processing delivery in an increasingly complex and high-volume environment.
The Role
As PV Case Processing Manager, you will act as a senior operational lead and subject-matter expert for case processing activities. While this is not a traditional line-management role initially, you will serve as the primary point of contact for internal stakeholders and external service providers, ensuring seamless end-to-end case management.
Key elements of the role include:
- Oversight of pre- and post-marketing case processing activities in a global environment
- Hands-on responsibility for vendor oversight, including selection, contracting, performance monitoring, and governance
- Acting as a senior escalation point for case quality, timelines, and compliance
- Close collaboration with internal PV, clinical, and quality teams
- Contribution to audit and inspection readiness, including CAPAs and updates to control documents
- Supporting the setup and execution of Safety Management Plans (SMPs)
- Monitoring KPIs and supporting continuous improvement initiatives
- Acting as a Business Continuity Coordinator for global safety operations
Annual case volumes exceed 10,000 ICSRs, driven by both ongoing clinical trials and marketed products, with further growth following recent acquisitions.
Working Model
- Hybrid role with an on-site expectation of approximately 3 days per week, with flexibility based on business needs
- Modern PV infrastructure and strong outsourcing model in place
Candidate Profile
This role will suit an experienced PV professional who enjoys operating at the intersection of operations, quality, and vendor management.
Essential requirements:
- At least 6+ years' experience in pharmacovigilance within the pharmaceutical industry
- Strong hands-on background in case processing in an international / global context
- Proven experience with Argus or equivalent global safety databases (mandatory)
- Experience overseeing outsourced PV activities and service providers
- Exposure to audits and inspections (EMA / global)
- Strong working knowledge of global PV regulations
- Fluent English
Desirable attributes:
- Ability to act as a senior operational lead without formal people management
- Confidence working with multiple stakeholders and vendors
- Proactive, structured, and quality-driven mindset
- Comfortable operating in a dynamic, high-volume environment
Job Types: Full-time, Permanent
Pay: From 75,000.00€ per year
Application Question(s):
- Do you have the right to work in France
Experience:
- Global PV Operations : 4 years (Preferred)
- Argus : 2 years (Preferred)
Work Location: Hybrid remote in 91190 Gif-sur-Yvette, France
