Pharmacovigilance Case Processing Officer (Gif-sur-Yvette, FR, 91190)
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Nous sommes un groupe pharmaceutique à dimension humaine, international et indépendant, gouverné par une Fondation. Notre modèle, singulier, fait notre fierté mais, surtout, nous permet de servir pleinement notre vocation : « Engagés pour le progrès thérapeutique au bénéfice des patients ».
Aujourd’hui leader mondial en cardiologie, nous avons choisi de devenir un acteur focalisé et innovant en oncologie d’ici 2030, en ciblant des cancers difficiles à traiter et en y consacrant plus de 70 % de notre budget R&D. Un défi que nous poursuivons en parallèle du développement de notre activité générique pour un accès à des soins de qualité pour tous, et à moindre coût.
Nous ? 22 000 passionnés de plus de 50 nationalités, portés par un esprit d’entreprenariat. Chaque jour nous avançons avec et pour les patients, avec et pour nos équipes, portés par l’envie de prendre soin, d’oser, de nous développer, de nous engager pour être utiles à celles et ceux qui en ont besoin.
Venez vivre et contribuez à faire vivre notre engagement #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.
Required skills & experience:
Education: Healthcare professional or scientific background (e.g., Pharmacy, Medicine, or Life Sciences).
Experience: Minimum of 4 years of experience in pharmacovigilance case management within an international environment
Hard skills:
Regulatory Knowledge: Excellent understanding of global pharmacovigilance (PV) regulatory requirements.
Technical: Proficient in pharmacovigilance databases (e.g., ARGUS) and other relevant safety information systems. MS office suite and other relevant tools
Literature review: Understanding of the literature surveillance process.
Quality Management: Skilled in quality control, CAPA drafting, and setting/reviewing Key Performance Indicators (KPIs).
Tools: Mastery of MS Office Suite and internal safety tools.
Languages: Fluent in English (both spoken and written).
Vendor oversight: Setting up/Reviewing key performance indicators to follow outsourced activities
Leadership skills:
Onboarding & Mentorship: Capacity to onboard new collaborators and provide necessary training and documentation to case processing vendors and LPVs.
Audit and inspections: Serve as a Subject Matter Expert (SME) for assigned activities/processes.
Soft skills:
Cross-functional Collaboration: Ability to work effectively with diverse teams outside of global safety unit, and external partners
Strong Communication: Proficiency in participating in operational meetings and regular team interactions in an international environment.
Organizational Skills: High level of organization to manage multiple tasks.
Adaptability: Ability to contribute to process optimization
Nous sommes engagés pour l’égalité des chances et le développement des talents dans toute leur diversité. Nous accordons autant de valeur à l’expérience qu’à l’envie de s’engager au quotidien pour être utile au progrès thérapeutique au bénéfice des patients. Si vous vous reconnaissez dans cette offre et ces quelques lignes, saisissez cette opportunité de nous rencontrer.
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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
23 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
+ 22 more countries
Seniority mix
77 of 112 peers have a known seniority level
Therapeutic area mix
10 of 112 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
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