Pharmacovigilance Coordinator

Stragen Group

Stragen is an international pharmaceutical group specialized in the development, manufacturing, and commercialization of specialty medicines. Operating across multiple countries, Stragen combines an entrepreneurial culture with strong governance, quality standards, and regulatory compliance in a highly regulated environment.

Reporting to the Head of Quality, the Pharmacovigilance Coordinator is responsible for maintaining and managing the Pharmacovigilance System of Stragen Group in compliance with PV requirements and acts as the contact person for the Stragen’s global PV activities.

Responsabilities:

· Acting as the designated contact person for global PV/vigilance system and activities.

· Ensure coordination of PV activities at Global level, in contact with the QPPV and all the affiliates of the Group.

· Ensure management of Medical Information system

· Establishment and maintenance of the Stragen’s Pharmacovigilance system for the products (PSMF)

· Ensure that pharmacovigilance activities and the submission of all pharmacovigilance-related documents (e.g. ICSRS, PSURs, RMPs…) is in accordance with the legal requirements and GVP.

· Ensure safety data reconciliations with Stragen partners and service providers.

· Guarantee that safety data reconciliation with QA and MedInfo and other concerned departments are performed.

· Review of commercial agreements and related PV/safety parts, preparation and update of Safety Data Exchange Agreements (SDEA).

· Perform initial and periodic qualification of PV partners: audits (agenda, audit reports and CAPA plans follow-up).

· Participate in Change Control process by providing the PV feedback.

· Inspection readiness, act as the point of contact in case of PV audit or inspection and coordinate the PV audit program, preparation, execution and CAPA plan implementation.

· Maintain awareness of Pharmacovigilance regulatory requirements and update the related company standard operating procedures and instructions (SOPs and WI) as required.

· Maintain training materials and ensure initial and periodical PV training of Stragen personnel.

· Ensure the performance of the PV system through the follow-up of PV metrics and KPIs.

· Provide oversight to the QPPV on all the listed PV activities.

· Perform other duties as assigned.

Requirements

· Adaptability to fast changing environment

· High level of integrity and professionalism

· Strong sense for organization, following up, tenacity and perseverance

· Excellent communication skills, both in written and spoken French and English

· Adept in using MS Office tools, Pharmacovigilance tools and databases

· Knowledge of the company’s products and services

· Scientist or PharmD

· Knowledge of drugs and pharmaceutical environment

· Knowledge of Pharmacovigilance regulation (national and international) and Pharmacovigilance tools and at least 6 years of experience

· Specific trainings in Pharmacovigilance/Quality