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Patient Safety and Pharmacovigilance (PSPV) Manager
Are you passionate about ensuring patient safety and compliance in the pharmaceutical industry? Join us as a PSPV Manager and play a pivotal role in safeguarding public health!
Role Overview: As a PSPV Manager, you will support and manage Pharmacovigilance (PV) Operations, creating and maintaining local PV policies and procedures. You will work closely with the Head of PSPV to establish and maintain a compliant local PV system, adhering to internal procedures and external regulations. Your role will ensure Boehringer Ingelheim UK and Ireland meet all Pharmacovigilance regulatory requirements and satisfy the expectations of key stakeholders.
Key Responsibilities:
1. Compliance and Reporting: Ensure robust safety reporting compliance according to current regulations.
2. Policy & Training: Develop, implement, and maintain local PV policies and procedures; oversee training plans and record management.
3. Stakeholder Management: Support oversight and management of external stakeholders and suppliers.
4. Strategic PSPV Integration: Promote PSPV awareness and collaboration in therapeutic projects, facilitating involvement in asset and evidence teams for comprehensive evidence generation and launch readiness.
5. Regulatory Intelligence: Monitor regulatory sites, evaluate updates, and adjust systems accordingly.
6. Safety Surveillance & Reporting: Conduct safety data reviews and signal management activities in a timely, compliant manner.
7. Process Improvement: Lead initiatives to enhance PV processes, ensuring compliance and inspection readiness.
8. Mentorship: Mentor junior staff and serve as a subject matter expert.
9. Support & Succession Planning: Assist the Head of PSPV in business contingency planning and act as a liaison for cross-functional relationships.
10. Routine PV Operations: Support management of PV systems, including the System Master File, KPIs, and repositories.
Required Competencies:
* Degree in Medical, Pharmacy, or Life Sciences; advanced degree preferred.
* At least 6 years of experience in Pharmacovigilance Operations or related fields.
* Experience with stakeholder management and liaising with health authorities.
* Deep understanding of PV regulations (ICH, CFR 21, EU GVP modules).
* Proficiency with safety databases and Quality Management Systems.
* Experience supporting PV audits and inspections.
* Ability to manage multiple projects in a fast-paced, regulated environment.
* Strong organizational and communication skills.
Why Join Us?
* Impactful Work: Contribute to patient safety by ensuring PV compliance.
* Collaborative Environment: Work with a dedicated team of professionals.
* Professional Growth: Opportunities for continuous learning and development.
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