Pharmacovigilance Case Processing Officer F/M (Gif-sur-Yvette, FR, 91190)
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We are an international and independent pharmaceutical group with a human scale, governed by a Foundation. Our unique model is our pride, but above all, it enables us to fully serve our purpose: "Committed to therapeutic progress for the benefit of patients."
Today a global leader in cardiology, we have chosen to become a focused and innovative player in oncology by 2030, targeting hard-to-treat cancers and dedicating more than 70% of our R&D budget to this field. We pursue this challenge alongside the development of our generics business to provide access to quality healthcare for all, at a lower cost.
Who are we? 22,000 passionate individuals representing over 50 nationalities, driven by an entrepreneurial spirit. Every day, we move forward with and for patients, and with and for our teams, fueled by the desire to care, to dare, to grow, and to commit ourselves to being useful to those who need us.
Come experience and help bring our commitment to life #MovedByYou
www.servier.com
The PV Case Processing Officer handles responsibility for the management of pharmacovigilance cases subcontracted to a vendor from collection to submission
Main responsibilities:
Monitoring Outsourced Activities & Case Management:
Manage pre- and post-marketing pharmacovigilance cases processed by Service provider: book-in, data entry, coding, narratives, quality control, medical review, and submission of applicable cases.
Ensure compliance with regulatory requirements, Safety Data Exchange Agreements (SDEA), and internal procedures.
Perform weekly quality control of cases processed by vendors.
Draft and validate deviation forms, root cause analysis, and CAPAs for cases submitted late to Regulatory authorities and other applicable recipients
Clinical Trial Support & Documentation:
Review protocols and electronic case report forms (eCRFs); write Safety Management Plans (SMP) for clinical trials.
Request updates for ARGUS database configurations (studies, products, reporting rules, etc.,).
Provide necessary documentation and training to vendors to ensure high-quality outsourced activities.
Coordination & Oversight:
Perform reconciliation with business partners, Local Pharmacovigilance teams (LPVs), and clinical databases.
Participate in study kick-off/end meetings, operational meetings with vendors/business partners, and in audits/inspections as a Subject Matter Expert (SME).
Contribute to process optimization, quality document writing, and the validation of vendor invoices.
What We Are Looking For
Your Background:
Education: Healthcare professional or scientific background (e.g., Pharmacy, Medicine, or Life Sciences).
Experience: A minimum of 4 years of expertise in Pharmacovigilance (PV) case management, ideally within a fast-paced international environment.
Technical Expertise (Hard Skills):
Regulatory Mastery: Deep understanding of global PV regulatory requirements and compliance standards.
Systems & Tools: Proficiency in safety databases (e.g., ARGUS) and the MS Office Suite.
Quality & Compliance: Proven track record in Quality Control, CAPA drafting, and managing Key Performance Indicators (KPIs).
Vendor Oversight: Experience in supervising outsourced activities, including setting and reviewing performance metrics.
Literature Surveillance: Solid understanding of the literature review and surveillance process.
Languages: Full professional proficiency in English (both written and spoken).
Leadership & Impact:
Mentorship & Onboarding: Ability to successfully integrate new collaborators and provide high-quality training and documentation to vendors and Local Pharmacovigilance Officers (LPVs).
Subject Matter Expertise: Act as a key SME for your assigned processes during internal audits and external inspections.
Key Attributes (Soft Skills):
Cross-functional Collaboration: A natural ability to build relationships and work effectively with diverse teams and external partners.
Strong Communication: A confident communicator, comfortable participating in operational meetings and interacting within a global network.
Organizational Excellence: Highly organized with the ability to manage multiple priorities simultaneously.
Continuous Improvement: An adaptable mindset with a drive to contribute to process optimization and operational efficiency.
We are committed to equal opportunity and fostering talent in all its diversity. We value experience just as much as the drive to commit every day to therapeutic progress for the benefit of patients. If you recognize yourself in this job offer and these values, seize this opportunity to meet us.
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Job details
How this role compares
Computed from every other active Pharmacovigilance role in our database, not just this employer's listings.
We currently track 112 comparable Pharmacovigilance roles across 40 biopharma companies.
Salary context
33 of 112 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 112 comparable roles
+ 17 more countries
Seniority mix
84 of 112 peers have a known seniority level
Therapeutic area mix
18 of 112 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.