Cutting-edge pharmaceutical company.
Located in Madrid, will report to the Chief Medical Officer, and manage a team of Safety Specialists, being responsible for:
- Ensure that the Pharmacovigilance System Master File is in place, accurate and up to date.
- Ensure that Good Pharmacovigilance Practices SOPs and Working instructions are in place up-to-date, trained on and actually followed. Comply with all applicable regulatory requirements, GVP and ICH guidelines, internal SOPs. Supervise the Quality Management System for PV activities.
- Ensure the tracking of metrics & KPIs on expedited and aggregate reporting and other key operational functions.
- Have authority and sign off on Risk Management Plan, PSUR and DSURs within regulatory requirements and timelines.
- Lead periodic and ad hoc Company's Safety Review meetings. Alert the CMO, Management Team and Competent Authorities in case of any change in the benefit/risk balance or emerging safety issues.
- Be fully responsible for safety medical review and deliverables. Ensure periodic medical review of all serious and non-serious adverse events by project for maintaining an overview of the safety profiles and any emerging safety issues on company products, signal detection and continuous assessment of the benefit/risk balance for all products.
- Supervise the regular systematic literature review to detect possible ICSRs and perform their medical review.
- Provide adequate initial and continuous training of personnel and third parties regarding PV activities and approve PV training material.
- Review, update all contracts & budget with Service Providers involved in PV activities.
- Supervise and collaborate closely with the Safety team, external Consultants and relevant Service Providers.
Skills, experiences and qualifications required:
- Medically qualified.
- Fluent English (a must).
- At least 7 years in a similar position
- Excellent oral and written communication skills within the Company and third parties, including regulatory bodies and service providers.