We are partnered with a fast-growing, family owned pharma company searching for someone to take ownership of the PV audits and inspections process, with a focus on regulatory intelligence and CAPA management.
- Support governance and oversight of the local pharmacovigilance function by developing and improving local processes, participating to the review of contracts and PV Agreements, and alerting PhV Affiliate Governance management of significant local PhV functions process deficiencies.
- Ensure oversight of local pharmacovigilance activities during the expansion of the portfolio.
- Participate to PhV audits and inspections, assists with the preparation of CAPAs.
- Assist the PSMF Coordinator to ensure the maintenance of the Pharmacovigilance System Master File.
- Collaborate with the process owners within pharmacovigilance and other functions engaged in the PhV System (such as commercial, GVP-, GCP-, GMP quality, medical affairs) who support local PhV processes and works cross-functionally to maintain global standards for pharmacovigilance activities to ensure patient safety.
- Collaborate with stakeholders and vendors to ensure PhV processes as mandated in approved existing agreements are adequately understood and followed.
- Support to EU QPPV office, e.g. notifications of change of EU QPPV, organisation and/or participation to EU QPPV - PhV management meetings, maintenance of xEVMPD.
- Minimum of 5 years pharmacovigilance experience in managing audits and inspections.
- Previous experience as a QPPV preferred.
- Understanding of global PV regulations (e.g, GVP, ICH) and implementing them.
- Strong tracking, coordination and project planning skills.
- Solid organizational, time management, and problem-solving skills.
- Good verbal and written communication skills.
- Must be fluent in English and comfortable in a fast-paced, demanding work environment