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Medical Writer and LRPPV Specialist
Il y a 2 mois
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 PV expertise to support the development and maintenance of our clients' products.
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
- Support other Medical Writers and the Activity Manager in reviews of 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
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
- Rigorous and 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:
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a highly skilled Medical Writer and LRPPV Specialist looking for a new challenge, please submit your application.
