Deputy Qualified Person for Pharmacovigilance

Hace 16 horas

vigo, galicia, España Planet Pharma Jornada completa

Position: Deputy Qualified Person for Pharmacovigilance (Deputy LQPPV)

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.

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