Vigilance Specialist M/F
Machine translation — original language: French.Show original
Your missions will be:
- Management of individual safety cases (spontaneous cases, solicited cases, clinical trials / medicinal products, medical devices): data collection, entry, evaluation, quality control, and regulatory submission
- Scientific literature monitoring
- Benefit/risk assessment and report writing (PSUR, signal detection, PGR/RMP, DSUR, clinical summaries...) : preparation, review, and submission
- Product expertise: act as a specialist for the portfolio products
- Monitoring of safety profiles: maintain a continuous overview of product safety profiles
- PSMF management: participate in the updating of the Pharmacovigilance System Master File
- International coordination: ensure interactions with subsidiaries
- Quality management: create, review, and maintain quality documentation
- Systems compliance: maintain vigilance systems in accordance with applicable regulatory and internal requirements
- Business continuity: guarantee the continuity of pharmacovigilance activities and provide on-call support if necessary
- Training: train employees on pharmacovigilance topics
- Materiovigilance: manage materiovigilance related to devices
- Audits & Inspections: participate in audits and inspections, as well as the management of corrective and preventive action plans (CAPA)
Profile sought
EDUCATION
- Pharmacist, Physician, or holder of at least a Master's degree (Bac+5) in biological / life sciences.
EXPERIENCE AND TECHNICAL SKILLS
- Experience: At least 2 years of experience in vigilance (in a regulatory agency or in the industry).
- Regulatory knowledge: Mastery of European regulations applied to vigilance (GVP modules, MDR 2017/745 regulation, etc.).
- Languages & Tools:
- Fluent English (reading, writing, speaking).
- Mastery of IT tools and HR/vigilance databases.
REQUIRED QUALITIES AND SOFT SKILLS
- Patient orientation: Place the interest and safety of patients at the heart of your daily tasks.
- Analytical and synthesis skills: Ability to process complex data with rigor.
- Priority management: Ability to manage several projects simultaneously in a dynamic environment and meet strict deadlines.
- Teamwork: Strong team spirit and ease in collaborating cross-functionally with other departments or subsidiaries.
- Communication: Excellent oral and written communication.