Local Safety Officer

ProductLife Group; France; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

ProductLife Group is seeking a Local Safety Officer to support pharmacovigilance activities in France on behalf of clients. You will act as the local PV expert and main contact for French authorities, ensuring compliance with local and international PV requirements.

The role requires strong PV knowledge, experience in local case management, and excellent communication to collaborate with clients, health authorities, and internal stakeholders.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Medicine, Life Sciences or related scientific discipline; equivalent experience considered.
• Minimum 2 years of experience in Pharmacovigilance and local PV case management.
• Strong knowledge of French and international pharmacovigilance regulations.
• Experience acting as a local pharmacovigilance contact in France is desirable.

Responsabilités

• Act as Local Safety Officer for PLG clients in France.
• Serve as a local pharmacovigilance contact with French regulatory authorities.
• Support Local Pharmacovigilance Person (LPPV) responsibilities where applicable.
• Ensure continuity of local vigilance activities and regulatory compliance.
• Maintain awareness of evolving French PV regulations and communicate updates.

Connaissances

Organizational skills

Planning

Attention to detail

Communication skills

Independence

Prioritization

Interpersonal skills

MS Office proficiency

MedDRA familiarity

Formation

Bachelor's or Master's in Pharmacy/Medicine/Life Sciences

Outils

Safety databases

MedDRA

Microsoft Word

Microsoft Excel

Microsoft Outlook

Description du poste

About ProductLife Group

ProductLife Group (PLG) is a global consulting and outsourcing organization specialized in supporting the life sciences industry throughout the entire product lifecycle. We provide expertise in regulatory affairs, pharmacovigilance, quality, medical information, and compliance services to pharmaceutical, biotechnology, and medical device companies worldwide.

Position Overview

We are seeking a Local Safety Officer to support our pharmacovigilance activities in France on behalf of our clients. The successful candidate will act as a local pharmacovigilance expert and key contact for French regulatory authorities, ensuring compliance with local and international pharmacovigilance requirements. This role requires strong pharmacovigilance knowledge, experience in local case management activities, and excellent communication skills to effectively collaborate with clients, health authorities, and internal stakeholders.

Key Responsibilities Local Safety Officer Activities

• Act as Local Safety Officer for PLG clients in France.
• Serve as a local pharmacovigilance contact and liaison with French regulatory authorities.
• Support Local Pharmacovigilance Person (LPPV) responsibilities where applicable.
• Ensure continuity of local vigilance activities and regulatory compliance.
• Maintain awareness of evolving French pharmacovigilance regulations and requirements.
• Notify local authorities of appointments and maintain required documentation.
• Communicate professionally with clients, authorities, and stakeholders within agreed timelines.

Pharmacovigilance Operations

• Perform receipt, processing, translation, quality control, tracking, and follow-up of Individual Case Safety Reports (ICSRs).
• Support local safety case management activities in compliance with applicable regulations and client requirements.
• Perform local regulatory safety submissions when required.
• Conduct reconciliation activities to ensure complete handling of vigilance reports.
• Support local medical information services when applicable.

Literature & Regulatory Intelligence

• Monitor local French literature and journals for safety information related to client products.
• Perform quality control and tracking of literature monitoring activities.
• Assist in the selection and review of local journals.
• Monitor French regulatory authority websites for safety updates and legislative changes.
• Track safety-related announcements and communicate relevant findings to clients.

Quality & Compliance

• Create and maintain local Pharmacovigilance System Master Files (PSMFs) when required.
• Support the development and maintenance of local SOPs and agreements.
• Review and update Safety Data Exchange Agreements (SDEAs), Pharmacovigilance Agreements (PVAs), and Technical Agreements.
• Participate in audits, inspections, and the implementation of corrective actions.
• Ensure compliance with confidentiality, data privacy, and quality standards.

Required Qualifications Education

• Bachelor's or Master's degree in Pharmacy, Medicine, Nursing, Life Sciences, or a related scientific discipline.
• Equivalent professional experience may also be considered.

Experience

• Minimum 2 years of experience in Pharmacovigilance.
• Experience in local PV case management, including case receipt, translation, submission, and follow-up.
• Strong knowledge of French and international pharmacovigilance regulations.
• Experience acting as a local pharmacovigilance contact in France is highly desirable.
• Previous experience in literature monitoring and regulatory intelligence is an advantage.
• Experience managing client interactions and projects is desirable.

Languages

• French: Native or fluent (written and spoken).
• English: Fluent (written and spoken).

Technical Skills

• Strong organizational and planning skills.
• Excellent attention to detail and quality mindset.
• Ability to work independently and manage priorities effectively.
• Strong interpersonal and communication skills.
• Good knowledge of Microsoft Office (Word, Excel, Outlook).
• Experience with safety databases and MedDRA is considered an advantage.