Group Procurement Outsourcing Expert

AXA Group Operations; Paris; Sur place; EUR 40 000 - 80 000; Plein temps

Résumé du poste

An exciting opportunity awaits a freelancer/consultant to join a dynamic team as a Local Contact Person for Pharmacovigilance and Regulatory Affairs. This role offers the chance to work in a multicultural environment and enhance your expertise in a fast-growing company. You will be responsible for liaising with local regulatory authorities, providing regulatory intelligence, and managing risk minimization efforts. The company values diversity and promotes a human-centric workplace, ensuring that all employees can thrive and contribute to meaningful projects. If you're ready to make a difference in the pharmaceutical landscape, this position could be your next great adventure.

Prestations

Competitive salary

Dynamic team

Multicultural environment

Strong emphasis on personal growth

Specialized trainings in pharmacovigilance

Friendly working environment

Social events

Qualifications

• Experience in the pharmaceutical or CRO industry is essential.
• Must have knowledge of ICH GVP and local regulatory requirements.

Responsabilités

• Act as the primary contact for local regulatory authorities.
• Manage local oversight of risk minimization measures.
• Support audits and inspections related to pharmacovigilance.

Connaissances

Pharmacovigilance

Regulatory Affairs

Communication Skills

Regulatory Intelligence

Quality Assurance

English Proficiency

MS Office

Formation

Bachelor's Degree in Life Sciences

Equivalent experience in Chemistry or Nursing

Outils

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Description du poste

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Regulatory • Issy-les-Moulineaux

Dernière mise à jour: il y a 15 heures

Job Description

This is an exciting opportunity for a freelancer / consultant to join our team as Local Contact Person for Pharmacovigilance and Regulatory Affairs at 0.5 FTE.

By working with us, you will have the opportunity to work in an international team and strengthen your expertise within the broad and diverse PV and Regulatory Affairs area.

Main responsibilities

• Primary contact person for local regulatory authority / Pharmacovigilance expert 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
• Review and linguistic input on local Product Information and Mock-ups
• Perform local non-indexed literature screening and screening of Regulatory Authority websites for potential Adverse Drug Reactions (ADRs) and safety information
• Support audits and inspections
• Handle local QA tasks such as suspected falsified products, quality alerts received from HA and other quality-related requirements received from the local market

Qualifications

• Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent experience
• Demonstrated experience within pharmaceutical or CRO industry or Regulatory body
• Must have experience within LCPPV / LCPRA roles
• PV training and / or working experience and other educational or professional background as required locally
• Expert knowledge of ICH GVP and most relevant legislation / local requirements for territories of competency
• Proficiency in English, both written and verbal and in local language
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
• Must currently be set up to work as a freelancer / consultant

Additional Information

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 in improving the lives of those around us.

Our Offer

• Competitive salary
• Dynamic team of colleagues in a fast-growing company – possibility for your quick career growth
• Multicultural environment, English as a company language
• Strong emphasis on personal and professional growth
• Extensive and specialized trainings in pharmacovigilance – internal trainings provided by skilled professionals
• Friendly working environment with several social events per year

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
• Collaborative Partnerships

We look forward to welcoming your application.