Deputy Qualified Person for Pharmacovigilance (LQPPV)

Planet Pharma; España; À distance; EUR 2 400 - 3 600; Temps partiel

Résumé du poste

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.

Responsabilités

• 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

Connaissances

Fluent in English

Fluent in Spanish

Fluent in Italian

Independent work

Safety databases knowledge

Formation

University degree in Life Sciences

Outils

Regulatory systems

Electronic reporting

Description du poste

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.