Position: Deputy/Local Qualified Person for Pharmacovigilance (QPPV)Location: Remote in SpainClient: CROType: Ad-hoc - 2 hours per month (ideal for Freelancers)
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Main ResponsibilitiesAct as the Local Qualified Person for Pharmacovigilance (LQPPV) for the Marketing Authorisation Holder (MAH) in the assigned country, in line with national pharmacovigilance legislationServe as the primary point of contact for the national Regulatory Authority (RA) on all pharmacovigilance mattersRespond to RA queries and support regulatory inspections and audits related to pharmacovigilanceAssist in the preparation for and conduct of RA audits and inspectionsEnsure awareness of and support for national risk minimisation measures for relevant productsFulfil any additional country-specific pharmacovigilance responsibilities required by local legislationEnsure continuity of responsibilities through a Deputy LQPPV, where required by national regulations
Main RequirementsUniversity degree in Life Sciences (e.G., Medicine, Pharmacy, Biochemistry, Veterinary) or equivalent medical/nursing qualificationExtensive pharmacovigilance experience with strong knowledge of national pharmacovigilance legislation and guidanceResident and operational in the relevant countryFluent in English (written and spoken)Fluent in at least one official local language of the countryAbility to operate independently as a delegate of the MAHProficiency with safety databases, regulatory authority systems, electronic reporting, and patient/product safety legislation