Deputy Qualified Person for Pharmacovigilance
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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 Main Requirements
* 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. #J-18808-Ljbffr
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