Medical Writer Senior – VAF 189
Location: Paris (Hybrid)
Category: Safety and Vigilance, Life Cycle
Contract Type: Permanent
Company Overview:
ProductLife Group (PLG) is dedicated to improving human health by providing regulatory compliance services to ensure the safe and effective use of medical solutions. For nearly 30 years, PLG has supported clients throughout the product life cycle, offering consulting and outsourcing services in regulatory affairs, quality and compliance, vigilance, and medical information across 130+ countries.
PLG is a fast-growing company, evolving from €25M in revenue in 2020 to €210M in 2024, with an ambitious goal to reach €600M by 2028, driven by a strong M&A strategy (23 acquisitions since 2020).
Key Responsibilities:
Medical Writing and Data Analysis:
Analyze data and prepare ad hoc reports/plans, including risk management, benefit/risk ratio, and signal detection.
Respond to questions from authorities (national and European surveys, ad hoc requests) requiring medical analysis.
Produce and validate safety reports (PSUR, PBRER, ACO, CES, DSUR, Signal Detection).
Lead and manage safety writing activities for multiple clients.
Pharmacovigilance (PV) Oversight:
Act as a Pharmacovigilance Responsible Person (RPV) for France for selected clients.
Coordinate with various internal and external stakeholders, including MAHs and ‘exploitants.’
Ensure compliance with safety and quality standards in line with regulatory requirements.
Project Management:
Manage project timelines and deliverables effectively.
Report on project progress and performance.
Participate in the drafting and review of quality documents, such as Standard Operating Procedures (SOPs) and Working Practice Documents.
Training and Documentation:
Provide medical training for staff from other divisions.
Participate in the development and maintenance of quality documents related to medical writing activities.
Candidate Requirements:
Education:
Pharmacist or Physician residing in France (meeting French PV regulatory requirements).
Experience:
Minimum 7 years of experience in PV activities, especially safety writing.
Previous experience acting as Deputy QPPV and/or RPV.
Worked with multiple clients and PV systems for at least 7 years, with direct participation in inspections by health authorities.
Technical Skills:
Extensive knowledge of PV regulations (GVP and BPPV) and safety writing processes.
Experience in case management.
Strong safety writing skills (drafting, quality control, and medical review).
Proficiency in safety databases and pharmacovigilance tools.
Experience with audits and inspections.
Soft Skills:
Strong leadership and team management abilities.
Rigor, reliability, and accountability.
Effective communication and stakeholder management.
Excellent time and priorities management.
Strong organizational and multitasking skills.
Business-oriented mindset.
Languages:
Fluent in French and English.
Gujarat :
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Siliguri |Illinois :
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China | Quarry Bay |Liaoning :
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Osaka | Tokyo |Shanghai Sai :
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Canada |Quebec :
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Brussels |Antwerp :
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Brazil | Sao paulo |Attica :
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Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
Lima |France :
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