Our client are looking for an experienced Quality Pharmacovigilance (PV) professional to support CAPA closure activities and the development of SOPs related to MAH (Marketing Authorisation Holder) oversight.
This is a hands‑on role requiring someone who can work independently, contribute immediately, and collaborate across multiple teams, so good communication is essential as there are several teams you will need to tie in with (regulatory, PV support team) etc
Key Responsibilities:
Draft and develop SOPs for MAH Oversight activities within Pharmacovigilance
Support CAPA plan execution and drive CAPA closure activities
Ability to collaborate with cross‑functional stakeholders including PV contractors (India), Regulatory Affairs, and QA teams
Ensure alignment and coordination across multiple contributors and reviewers
PPV audits experience is a plus
Required Experience:
Strong QA Pharmacovigilance (PV) background, including knowledge of GVP and routine PV activities
Familiarity with MAH responsibilities and oversight requirements, including EU PV/PSUR expectations
Solid Quality/QA experience, including SOP development and CAPA management
Experience working with e QMS systems
Ability to work autonomously and “hit the ground running” with minimal supervision
Strong communication skills, particularly in coordinating with remote/international teams
