Position: Deputy/Local Qualified Person for Pharmacovigilance (QPPV)
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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
Resident and operational in the relevant country
Fluent in English (written and spoken)
Fluent in at least one official local language of the country
Ability to operate independently as a delegate of the MAH
Proficiency with safety databases, regulatory authority systems, electronic reporting, and patient/product safety legislation
ABOUT 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 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really make us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
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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