Freelance Consultant 1 FTE Local Safety Officer in France

Company Description

We are PrimeVigilance (part of Ergomed Group), a specialized mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.

Job Description

This is an exciting opportunity for a freelancer / consultant to join our team as Local Safety Officer in France.

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

• PV Cases Handling

Receipt of initial or follow-up AE cases incl. combination products as applicable, case reception, case registration and documentation in the local tracker.

Translation of ICSR case information into English on the ICSR form (or of Eudravigilance cases).

Transmission of the case to IPV case management team.

Cases Fup handling contact of the reporters, archiving.

Case closure: Quality control of all tasks performed, file complete and anonymization.

QC of English translation of cases proceeded by LSO (during DSO back-up period).

• Signal detection

Reception and registration of the listings from global, selection of list of cases to review.

Review of the causality of all unexpected or fatal cases (qualitative analysis).

Transmission of the cases with causality assessed as probable or certain for LSO validation review and selection of the cases received over the month.

Identification of potential quantitative signal according to the threshold and transmission to LSO for validation / analysis (quantitative analysis).

• Monthly identification / selection of cases of non-conform use received and transmission to the LSO for analysis.
• PV Quality Management System - review / comments of the quality documents created or updated by the LSO.
• Inspections and audits - support to HA inspection/ Internal audits preparation support and participation.
• Reconciliation - expedited reporting reconciliation incl. check of compliance and CAPA (for non E2B countries only). Conduct reconciliation for local studies, third parties.
• Provision of local regulatory intelligence screening and expert advice.
• Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues.
• Perform local non-indexed literature screening and screening of Regulatory Authority website/s for potential Adverse Drug Reactions (ADRs) and safety information.
• Training - Update of training material, face to face training of new employees.
• RQD preparation and presentation of PV data/KPI (LSO back-up).
• Monthly pilotage with CPO.
• Management of Generic PV mailbox.
• Interfaces / Stakeholder management.
• Involvement in local labelling safety related changes e.g. local translation or update of safety sections, if applicable (exceptional).

Qualifications

• Must reside in France.
• Bachelor's Degree in Life Sciences or Chemistry, Nursing, or equivalent experience.
• Minimum 2-3 year demonstrated experience within pharmacovigilance industry.
• 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 and French, both written and verbal.
• 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 on improving the lives of those around us.

Our offer

• Dynamic team of colleagues in a fast-growing company.
• Multicultural environment, English as a company language.
• Friendly working environment.

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.