Regulatory Medical Writer and PV Expert

il y a 4 jours


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

ProductLife Group is seeking a highly skilled Medical Writer and LRPPV Specialist to join our team. As a key member of our dynamic team, you will contribute to the activities performed in our Hub.

Key Responsibilities
  • Act as LRPPV in France and serve as the single point of contact to French health authorities.
  • Respond to questions from authorities (national, European surveys, ad hoc answers) requiring medical analysis.
  • Exchange periodically with Marketing Authorization Holders regarding PV systems.
  • Prepare and review safety reports, including Development Safety Update Reports (DSURs), Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs), Risk Management Plans (RMPs), and Addendum to Clinical Overviews (ACOs).
  • Understand and interpret clinical and scientific reports to accurately capture safety and efficacy data.
  • Present scientific data, analyze, and appraise clinical, biomedical, and scientific reports in a systematic, accurate, fair, and balanced way.
  • Conduct comprehensive literature searches to support research, clinical evidence, product development, risk analysis, and regulatory submissions.
  • Write ad hoc reports based on these literature searches.
  • Identify suspected spontaneous adverse drug reaction reports and ensure they are accurately reported to the appropriate Pharmacovigilance LOB in line with legal and company requirements.
  • Provide timely, accurate, and clear verbal and written information in response to enquiries about PLG customers' products or therapy areas.
Quality and System Management
  • Support other Medical Writers and the Activity Manager in reviewing metrics to assess accuracy, quality, and regulatory compliance of MI VI outputs.
  • Participate in training as required for ProductLife Group.
  • Comply with the company's policies and procedures to meet statutory, quality, and business requirements within the overall strategy and objectives.
Requirements
  • Pharmacist or medical degree.
  • Minimum 4 years of experience in PV operational activities.
  • Experience in preparing signal and aggregate reports (PSUR, DSUR, etc.).
  • BPPV France/GVP.
  • Knowledge of case management.
  • Skills: database experience, knowledge of current regulations, process-oriented, rigorous, ability to work in a team, use of Microsoft Office tools, ability to multitask, flexibility, and excellent communication skills in French and English for business continuity.


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