Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV / LCPRA) - Freelance -[...]

PrimeVigilance; Paris; À distance; EUR 45 000 - 65 000; Plein temps

Résumé du poste

PrimeVigilance recherche un Responsable Local pour la Pharmacovigilance et les Affaires Réglementaires. Le candidat idéal devra assurer la conformité aux exigences locales et collaborer étroitement avec les autorités réglementaires. Ce rôle exige une expertise en pharmacovigilance et un diplôme en sciences de la vie ou équivalent. Un environnement de travail inclusif et des opportunités de développement de carrière sont proposés.

Prestations

Opportunités de formation et développement de carrière

Environnement de travail amical et solidaire

Qualifications

• Expérience minimum de 3 ans dans l'industrie pharmaceutique ou une autorité réglementaire.
• Minimum 2 ans dans un rôle de LCPPV ou expérience en pharmacovigilance.
• Connaissance approfondie des exigences ICH GVP.

Responsabilités

• Contact principal pour les autorités réglementaires locales.
• Collecte et rapport des ADRs localement.
• Gestion des mesures de minimisation des risques.

Connaissances

Communication

Analyse de risque

Gestion des ADRs

Connaissance réglementaire

Microsoft Office

Formation

Baccalauréat en Sciences de la Vie ou Chimie

Diplôme en Pharmacie ou expérience professionnelle équivalente

Description du poste

The Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV / LCPRA) serves as the primary local representative to ensure compliance with national pharmacovigilance and regulatory requirements. This dual-role position is responsible for executing PV and RA activities at the local level, supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle.

Main responsibilities

• Primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirements
• Prompt and effective communication with local regulatory authorities
• Provision of local regulatory intelligence screening and expert advice
• Collection and reporting of locally suspected ADRs or ICSRs (FUs, translations)
• Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues
• Preparation and collection of documentation for submissions to the regulatory authorities
• Review and linguistic input on local Product Information and Mock-ups
• Development and implementation of local pharmacovigilance system in compliance with Global MAH's system and local regulations
• Perform local non-indexed literature screening and screening of regulatory authority website / s for potential Adverse Drug Reactions (ADRs) and safety information
• Maintain accurate records and documentation at local level
• Provide support to the RA & PV Global operations team
• Ensure compliance with MAH's and PrimeVigilance's procedures
• Support audits and Inspections
• Handle local QA tasks such as suspected falsified products, quality alerts received from health authorities and other quality-related requirements received from the local market

Qualifications

• Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience
• Minimum 3 years within pharmaceutical or CRO industry or regulatory authority
• Minimum 2 years within LCPPV role, or relevant pharmacovigilance experience in safety-related position
• Pharmacovigilance training and / or working experience and other educational or professional background as required by local regulations
• Prior experience in Regulatory Affairs is preferred but not mandatory
• Expert knowledge of ICH GVP and relevant local legislation / regulatory requirements in territories of competency
• Proficiency in English and French, both written and verbal
• Strong skills in Microsoft Office applications, including Word, Excel, and PowerPoint

Additional Information

Why PrimeVigilance

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer :

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging

We look forward to welcoming your application.

LI remote