Oferta de socioPosition: Deputy/Local Qualified Person for Pharmacovigilance (QPPV)
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 PHARMA
Planet 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 makes 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.
