Job Details
VAF189 - Medical Writer Senior
Île-de-France,  France | Posted - 14/03/2025
Job Description

About Productlife Group

ProductLife Group’s mission is to improve human health by delivering regulatory compliance services for the safe and effective use of medical solutions. Since almost 30 years, ProductLife Group (PLG) supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 130 countries. It provides consulting and outsourcing services in the areas of regulatory affairs, quality and compliance, vigilances and medical information, covering both established products and innovative therapeutics & diagnostics. With a goal of continuously improving the value delivered to people and customers, PLG is committed to long-term partnership, innovation, flexibility, and cost efficiency.

PLG is a fast-growing organization, evolving from €25m revenue in 2020 to €210m in 2024, and with an ambition to reach €600m by 2028. The development being supported by a continued M&A strategy (23 build-ups closed since 2020).

 

Key responsibilities
  • Acting as LRPPV in France and as single point of contact to French health authorities
  • Acting as a Back up for local PV in FR (so acting as backup)
  • Handling signal detection, Off label use reports and aggregate reports (DSUR, PSUR, RMP, ACP etc) PSMF, SDEA writing, Regulatory intelligence activities
  • Capability to handle deputy and EU QPPV role (in future)
  • Be involved in audits and health authority inspections on behalf of PLG clients
  • In addition to the QPPV role, act as a Pharmacovigilance Responsible Person for France for selected clients
  • Leading and managing Safety Writing (PSUR/PBRER/ ACO/CES/DSUR/SIGNAL DETECTION)
  • Coordinating with various internal and external stakeholders, including MAH and ‘exploitants’
  • Ensuring compliance with safety and quality standards
  • Managing project timelines
  • Reporting on project progress and performance
 
Profile
Education : Pharmacist, Physician residing in France (French PV regulatory requirement)
Experience : 
  • At least 7 years’ experience in PV activities /  especially in safety writing.
  • Acted at least as deputy QPPV and/or RPV
  • Having worked with multiple clients, different PV system for minimum of 7 years. Direct participation in inspections from the health authorities.
Languages : French and English
Technical skills :
  • Extensive experience in PV and in-depth knowledge of health and safety regulations (GVP and BPPV…)
  • Knowledge of case management at least
  • Good safety writing skills (drafting, quality control and medical review)
  • Proficiency in safety databases software
  • Adept in using MS Office tools and Pharmacovigilance tools
  • Knowledge of the Customer’s products and services
  • Experience in audits and inspections

Soft skills :

  • Strong leadership, and team management skills would be an asset
  • Rigor and reliability and accountability
  • Effective Communication
  • Time and Priorities management
  • Excellent organisational and multitasking abilities
  • Business mindset