19 oct
|
Planet Pharma
|
La Coruña
19 oct
Planet Pharma
La Coruña
Position:
Deputy Qualified Person for Pharmacovigilance (Deputy LQPPV)
Location:
Remote in Spain
Client:
CRO
Type:
Ad-hoc - 2 hours per month (idóneo 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.
J-*-Ljbffr
📌 Deputy Qualified Person For Pharmacovigilance (La Coruña)
🏢 Planet Pharma
📍 La Coruña