Local PV Consultant (Hybrid)

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Senior Area/Local Safety Officer Consultant for 12 months Contract with possibility of extension to join one of our clients.

Hybrid Model: 2 days a week

Location: Issy‑Les‑Moulineaux, France

Language

French as a mother tongue and fluent English.

The Senior Area Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners.

They will ensure that appropriate product vigilance and risk management systems are set in place to ensure appropriate oversight of products within its responsibility.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client‑facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high‑trust environment

with the client’s counterparts.

Main Job Tasks and Responsibilities

Job Description

Senior Area Safety Officer, Local PV France

This position reports into Area Safety Head and is based in Issy‑Les‑Moulineaux, France.

Position Summary

The Senior Area Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners.

They will ensure that appropriate product vigilance and risk management systems are set in place to ensure appropriate oversight of products within its responsibility.

Principal Responsibilities

Oversight of the PV System & Overall responsibilities

• Provide oversight of vendor resources in the countries in scope.
• Support the Area Safety Head in providing relevant local information for the European Economic Area/ UK Pharmacovigilance System Master File (PSMF).
• Regularly review the French PSMF and suggest necessary updates.
• Record self‑identified non‑conformances and collaborate with the global team to investigate non‑conformances while developing and implementing effective Corrective and Preventative Actions (CAPAs).
• Provide regular reporting of the local vigilance activities during dedicated committees.

Safety Management & Reporting

• Support the Area Safety Head in the responses to safety‑related health authority queries.
• Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).
• Maintain oversight of proper identification of local literature articles for Adverse Event (AE) reporting as required.
• Perform document management and archiving as required.
• Ensure proper documented training on safety reporting responsibilities of LOC personnel and maintenance of awareness of safety reporting in general.
• Perform regulatory monitoring for impact on vigilance activities and responsibilities.
• Collaborate with the global and local teams to notify local health authorities of any safety issues including SSI/ESI and Signals.
• Manage planification and reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other departments as applicable.
• Maintain up-to‑date knowledge of local requirements for pharmacovigilance, cosmetovigilance, materiovigilance and nutrivigilance, including reporting requirements (for all applicable product classes in the territory) and collaborate with the global team to implement process changes required for identification of new requirements.
• Support the Area Safety Head in the pharmacovigilance agreements set‑up and updates.
• Perform translation for ICSR and PV‑related documents, as required.
• Contribute to the elaboration of safety data during the French good committee use.
• Provide technical and strategic input and participate in projects/ workstreams led by the Medical Safety teams or LOC.

Procedural Document

• Develop, update, and implement local procedures to ensure compliance with the global procedures and national requirements.
• Ensure current knowledge of all relevant company procedures and training.

Audit & Inspection Readiness

• Support local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA plans as applicable.

Business Continuity

• Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage) and back‑up the Area Safety Head during their absence.

Qualifications

The minimum knowledge, skill, related experience, and ability requirements for the position.

Education

Health care science professional e.g.: (Pharmacist, nurse…)

Years of Related Experience

At minimum 3 years’ experience.

Knowledge, Skills, Abilities

• Pharmaceutical industry experience including product vigilance responsibility role.
• Proven ability to organize workflow activities in an autonomous manner.
• Awareness of and familiarity with industry principles of product vigilance, drug development, and pharmacology.
• Knowledge of global, regional, and local procedural documents as applicable.
• Computer literate with knowledge of relevant IT safety systems.
• Good verbal and written communication skills.
• Ability to establish and maintain open relationships within the organization and with authorities.
• Demonstrable knowledge of all local requirements and of global aspects of product safety.
• Fluency in the English language.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full‑service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high‑quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia‑Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly‑qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.