Regulatory Medical Writer and PV Expert
il y a 4 jours
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.
- 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.
- 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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