Responsibilities

  • Analysis of data and preparation of ad hoc reports/plans in the framework such as: risk management, benefit/risk ratio, signals,
  • Answers to questions from authorities (national, European surveys, ad hoc answers) requiring medical analysis
  • Production and validation of safety reports (written by this division or by the Case Management Business Unit) depending on seniority and after successful experience in writing Medical training for staff from other divisions
  • Participation in the drafting of quality documents related to the Medical writing specific activities (i.e., Standard Operating procedures (SOPs) and Working Practice Documents)
  • In addition, 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 organizational and multitasking abilities
  • Business mindset

Publish Date

17 March, 2025

Spontaneous Application

Medical Writer Senior - VAF 189

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