Medical Writer Senior - VAF 189

ProductLife Group; Paris; Sur place; EUR 60 000 - 85 000; Plein temps

Résumé du poste

Une entreprise innovante dans le secteur de la santé recherche un responsable de la pharmacovigilance. Le candidat idéal doit avoir un diplôme de pharmacien ou de médecin et posséder plus de 7 ans d'expérience dans le domaine. Vous serez responsable de la rédaction de rapports de sécurité, de l'évaluation de la conformité réglementaire et de la gestion des interactions avec les autorités de santé. Ce poste exige d'excellentes compétences en rédaction et en communication, ainsi qu'un bon sens de l'organisation pour coordonner avec divers intervenants.

Qualifications

• Au moins 7 ans d'expérience en pharmacovigilance, surtout dans la rédaction de sécurité.
• Expérience comme QPPV adjoint et/ou RPV.
• Participé aux inspections des autorités de santé.

Responsabilités

• Analyse des données et préparation de rapports de sécurité.
• Rédaction et validation des rapports de sécurité.
• Gestion des délais de projet et coordination avec divers acteurs.

Connaissances

Conduite de projet

Rédaction médicale

Analyse de données

Communication efficace

Rigueur et fiabilité

Formation

Pharmacien

Médecin

Outils

Logiciels de pharmacovigilance

MS Office

Description du poste

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ProductLife Group’s mission is to improve human health by delivering regulatory compliance services for the safe and effective use of medical solutions. Since almost 30 years, ProductLife Group (PLG) supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 130 countries. It provides consulting and outsourcing services in the areas of regulatory affairs, quality and compliance, vigilances and medical information, covering both established products and innovative therapeutics & diagnostics. With a goal of continuously improving the value delivered to people and customers, PLG is committed to long-term partnership, innovation, flexibility, and cost efficiency.

PLG is a fast-growing organization, evolving from €25m revenue in 2020 to €210m in 2024, and with an ambition to reach €600m by 2028. The development being supported by a continued M&A strategy (23 build-ups closed since 2020).

Group 10 Responsibilities

• Analysis of data and preparation of ad hoc reports/plans in the framework such as: risk management, benefit/risk ratio, signals,
• Answers to questions from authorities (national, European surveys, ad hoc answers) requiring medical analysis
• Production and validation of safety reports (written by this division or by the Case Management Business Unit) depending on seniority and after successful experience in writing Medical training for staff from other divisions
• Participation in the drafting of quality documents related to the Medical writing specific activities (i.e., Standard Operating procedures (SOPs) and Working Practice Documents)
• In addition, act as a Pharmacovigilance Responsible Person for France for selected clients
• Leading and managing Safety Writing (PSUR/PBRER/ ACO/CES/DSUR/SIGNAL DETECTION)
• Coordinating with various internal and external stakeholders, including MAH and ‘exploitants’
• Ensuring compliance with safety and quality standards
• Managing project timelines
• Reporting on project progress and performance

Group 12 Profile

Education : Pharmacist, Physician residing in France (French PV regulatory requirement)

Experience :

• At least 7 years’ experience in PV activities / especially in safety writing.
• Acted at least as deputy QPPV and/or RPV
• Having worked with multiple clients, different PV system for minimum of 7 years. Direct participation in inspections from the health authorities.

Languages : French and English

Technical skills :

• Extensive experience in PV and in-depth knowledge of health and safety regulations (GVP and BPPV…)
• Knowledge of case management at least
• Good safety writing skills (drafting, quality control and medical review)
• Proficiency in safety databases software
• Adept in using MS Office tools and Pharmacovigilance tools
• Knowledge of the Customer’s products and services
• Experience in audits and inspections

Soft skills:

• Strong leadership, and team management skills would be an asset
• Rigor and reliability and accountability
• Effective Communication
• Time and Priorities management
• Excellent organizational and multitasking abilities
• Business mindset