PV QA Consultant

I am currently looking for a PV QA (Pharmacovigilance Quality) Consultant based in Paris, for a hybrid role onsite 3 days a week in Paris.

Start: ASAP (December 8th latest)

Duration: 6 months contract

Location: Paris

Onsite/Remote: Hybrid (3 days onsite in Paris)

Language: English and French Fluency

Key Responsibilities:

* Maintain, develop, and monitor the Pharmacovigilance (PV) Quality Management System (QMS) to ensure compliance with regulatory requirements and internal standards.

* Act as the primary point of contact for Global Patient Safety (GPS)/PV functions regarding the Global PV QMS.

* Contribute to the development of quality objectives related to the PV QMS, ensuring alignment with Global Quality objectives.

* Participate in periodic reviews of the PV QMS and support continuous quality improvements.

* Manage CAPA activities, including coordinating CAPA plan development, approval, tracking, monitoring, and reporting.

* Handle PV-related quality assurance activities such as deviations, audits, and quality oversight.

* Support effective communication and collaboration with cross-functional teams involved in PV and drug safety operations.

Requirements:

* Previous pharmaceutical industry experience required.

* Experience in Pharmacovigilance quality management, including QMS oversight.

* Proven experience handling deviations, audits, CAPA management, and general PV/drug safety quality assurance activities.

* Fluency in French and English.