Deputy Qualified Person for Pharmacovigilance
Hace 16 horas
vigo, galicia, España
Planet Pharma
Jornada completa
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Position: Deputy Qualified Person for Pharmacovigilance (Deputy LQPPV)
Location: Remote in Spain
Client: CRO
Type: Ad-hoc - 2 hours per month (ideal for Freelancers)
Main Responsibilities- Act as the Local Qualified Person for Pharmacovigilance (LQPPV) for the Marketing Authorisation Holder (MAH) in the assigned country, in line with national pharmacovigilance legislation
- Serve as the primary point of contact for the national Regulatory Authority (RA) on all pharmacovigilance matters
- Respond to RA queries and support regulatory inspections and audits related to pharmacovigilance
- Assist in the preparation for and conduct of RA audits and inspections
- Ensure awareness of and support for national risk minimisation measures for relevant products
- Fulfil any additional country-specific pharmacovigilance responsibilities required by local legislation
- Ensure continuity of responsibilities through a Deputy LQPPV , where required by national regulations
- University degree in Life Sciences (e.g., Medicine, Pharmacy, Biochemistry, Veterinary) or equivalent medical/nursing qualification
- Extensive pharmacovigilance experience with strong knowledge of national pharmacovigilance legislation and guidance
- Fluent in English (written and spoken)
- Fluent in Spanish and Italian
- Ability to operate independently as a delegate of the MAH
- Proficiency with safety databases, regulatory authority systems, electronic reporting , and patient/product safety legislation
We are an equal opportunities Recruitment Business and Agency.
We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
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