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Senior Medical Writer and Pharmacovigilance Specialist

Il y a 2 mois

Paris Louvre, Île-de-France ProductLife Group Temps plein
Job Description

Job Title: Medical Writer and LRPPV Specialist

Company: ProductLife Group

Location: Remote (France)

Job Type: Full-time

Experience: 4+ years in PV operational activities

Education: Pharmacist or medical degree

About the Role:

We are seeking a highly skilled Medical Writer and LRPPV Specialist to join our dynamic team at ProductLife Group. As a key member of our Pharmacovigilance team, you will be responsible for providing medical writing and regulatory support to our clients.

Key Responsibilities:

  • Act as LRPPV in France and single point of contact to French health authorities
  • Provide medical analysis and responses to questions from authorities
  • Exchange information with Marketing Authorization Holders regarding PV systems
  • Produce and validate reports, including signal detection, off-label use reports, and aggregate reports
  • Represent medical writing as part of a global, cross-functional team
  • Assist in the preparation of Standard Operating procedures (SOPs) and Working Practice Documents
  • Ensure adherence to GCP, ICH guidelines, SOPs, and client templates
  • Provide frequent and purposeful communication with stakeholders
  • Prepare, review, and provide feedback for safety reports, including DSURs, PSURs/PBRERs, RMPs, and ACOs
  • Understand and interpret clinical and scientific reports to capture safety and efficacy data
  • Conduct comprehensive literature searches to support research, clinical evidence, product development, risk analysis, and regulatory submissions
  • Write ad hoc reports based on literature searches
  • Identify suspected spontaneous adverse drug reaction reports and ensure accurate reporting
  • Provide timely, accurate, and clear information in response to enquiries about PLG customers' products or therapy areas

Requirements:

  • Pharmacist or medical degree
  • 4+ years experience in PV operational activities
  • Experience in preparation of signal and aggregate reports (PSUR, DSUR etc.)
  • BPPV France/GVP knowledge
  • Case management skills
  • Database experience preferred
  • Knowledge of current regulations
  • Process-oriented and rigorous
  • Ability to work in a team
  • Use of Microsoft Office tools
  • Ability to multitask
  • Flexibility
  • Excellent communication skills in French and English

What We Offer:

At ProductLife Group, we offer a dynamic and supportive work environment, competitive salary, and opportunities for professional growth and development.