- This position is responsible for providing primarily ex-US Pharmacovigilance (PVG) audit support for QA management and oversight of global PVG activities of Clinical Development teams to the Head of company QA-GCP. Secondarily this position is responsible for GCP support for clinical development.
- This job will include the execution and management of company QA-PVG/GCP audits and the provision of PVG/GCP guidance and advice across relevant Post-marketing and Clinical Development area.
Duties and Responsibilities
- Establishing, maintaining and executing the European GPvP audit program (Processes, affiliates, vendors).
- Tracking, reviewing and confirming effectiveness of CAPAs related to safety reporting.
- Establishing and maintaining the European PVG Quality System including SOPs in collaboration with PVG and ensuring continuous process improvement.
- Reviewing key pharmacovigilance documents, e.g. PSMF, reports, and regulatory submissions.
- Defining and reporting quality metrics.
- Assist in preparing and hosting Inspections in collaboration with PVG.
- Support the development the PVG training program in collaboration with PVG.
- Coordinate responses and corrective actions from audit findings.
- Provide GCP advice and support to company Clinical Operations and other relevant functions.
- Stay abreast of Pharmacovigilance and Safety regulations, EU clinical trial requirements, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the EU and other regions, as appropriate.
- Alert QA Upper Management of internal and external PVG non-compliance and clinical trial issues in a timely manner.
- Become thoroughly familiar with assigned company compounds and protocols.
- Bachelor’s degree
- 5 – 10 years’ experience in a pharmaceutical or bio-pharmaceutical company in a PVG/GCP QA role with a minimum of 5 years’ experience in evaluating/managing PVG audits.
- Ability to travel up to 50%.
- Strong written and oral communication skills.
- Prior inspection experience preferred.