Remote Deputy LQPPV — Pharmacovigilance Specialist

Planet Pharma

España

Remote

EUR 2,400 - 3,600

Part time

14 days+

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Job summary

Planet Pharma is seeking a Deputy Qualified Person for Pharmacovigilance (Deputy LQPPV) to work remotely from Spain on an ad-hoc basis (2 hours per month). You will serve as the Local Qualified Person for Pharmacovigilance for MAH, liaising with the national regulatory authority and supporting audits and risk minimisation measures.

The role requires a life sciences degree, extensive PV experience, and fluency in English, Spanish, and Italian.

Qualifications

  • University degree in Life Sciences 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.

Responsibilities

  • Act as the Local Qualified Person for Pharmacovigilance (LQPPV) for the MAH in the assigned country, in line with national pharmacovigilance legislation.
  • Serve as the primary point of contact for the national Regulatory Authority 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

Skills

Fluent in English
Fluent in Spanish
Fluent in Italian
Independent work
Safety databases knowledge

Education

University degree in Life Sciences

Tools

Regulatory systems
Electronic reporting

Job description

Planet Pharma is seeking a Deputy Qualified Person for Pharmacovigilance (Deputy LQPPV) to work remotely from Spain on an ad-hoc basis (2 hours per month). You will serve as the Local Qualified Person for Pharmacovigilance for MAH, liaising with the national regulatory authority and supporting audits and risk minimisation measures.

The role requires a life sciences degree, extensive PV experience, and fluency in English, Spanish, and Italian.

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