Position:Deputy/Local Qualified Person for Pharmacovigilance (QPPV)Location:Remote in SpainClient:CROType:Ad-hoc - 2 hours per month (idóneo for Freelancers)Main ResponsibilitiesAct as theLocal Qualified Person for Pharmacovigilance (LQPPV)for the Marketing Authorisation Holder (MAH) in the assigned country, in line with national pharmacovigilance legislationServe as theprimary point of contactfor the national Regulatory Authority (RA) on all pharmacovigilance mattersRespond to RA queries and supportregulatory inspections and auditsrelated to pharmacovigilanceAssist in thepreparation for and conduct of RA audits and inspectionsEnsure awareness of and support fornational risk minimisation measuresfor relevant productsFulfil anyadditional country-specific pharmacovigilance responsibilitiesrequired by local legislationEnsure continuity of responsibilities through aDeputy LQPPV, where required by national regulationsMain RequirementsUniversity degree in Life Sciences(e.g., Medicine, Pharmacy, Biochemistry, Veterinary) or equivalent medical/nursing qualificationExtensive pharmacovigilance experiencewith strong knowledge of national pharmacovigilance legislation and guidanceResident and operationalin the relevant countryFluent in English(written and spoken)Fluent in at least one official local languageof the countryAbility tooperate independentlyas a delegate of the MAHProficiency withsafety databases, regulatory authority systems, electronic reporting, and patient/product safety legislationABOUT PLANET PHARMAPlanet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London.We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of ****+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.Our specialist knowle