France Local Safety Officer: Pharmacovigilance Expert

ProductLife France

Courbevoie

Hybride

EUR 65 000 - 90 000

Plein temps

14 jours+

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Avantages offerts par ce poste

Hybrid & flexible working
International by design
Continuous learning
Inclusive & diverse culture

Résumé du poste

ProductLife Group is seeking a Local Safety Officer to lead pharmacovigilance activities in France on behalf of clients. The role focuses on serving as a local PV expert, managing case processing, and ensuring compliance with regulatory requirements.

You will liaise with French authorities and internal teams to maintain high standards of safety vigilance and data integrity. The ideal candidate has 2+ years in PV, strong French regulatory knowledge, and excellent communication.

Qualifications

  • 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.
  • Experience with literature monitoring and regulatory intelligence is an advantage.
  • Experience managing client interactions and projects is desirable.

Responsabilités

  • 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.
  • Perform receipt, processing, translation, quality control, tracking, and follow-up of ICSRs.
  • Support local safety case management activities in compliance with 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.
  • Monitor local French literature and journals for safety information.

Connaissances

Organizational skills
Attention to detail
Independent worker
Communication skills
Interpersonal skills

Formation

Bachelor's or Master's degree in Pharmacy, Medicine, Life Sciences or related

Outils

Microsoft Office
Safety databases
MedDRA

Description du poste

ProductLife Group is seeking a Local Safety Officer to lead pharmacovigilance activities in France on behalf of clients. The role focuses on serving as a local PV expert, managing case processing, and ensuring compliance with regulatory requirements.

You will liaise with French authorities and internal teams to maintain high standards of safety vigilance and data integrity. The ideal candidate has 2+ years in PV, strong French regulatory knowledge, and excellent communication.

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