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QPPV

Job Title: QPPV
Contract Type: Permanent
Location: Dublin
Industry:
REF: 123486
Contact Name: Laurentina Kennedy
Contact Email: laurentina@rftgroup.ie
Job Published: about 1 month ago

Job Description

QPPV Permanent Dublin City
Our client, a major pharmaceutical company based in Dublin City wish to appoint an experienced QPPV to join their team.

Responsibilities:
To ensure that the pharmacovigilance system is compliant with applicable EU regulatory requirements
Update the Pharmacovigilance System Master File (PSMF)
Update and oversee Safety Data Exchange Agreements (SDEA)
Functionally oversee global national pharmacovigilance contact persons
Provide input to PV training and evaluation standards
Maintain awareness of local PV Regulatory requirements and implementation plans
Responsible for the validation status, validation failures, corrective actions and significant
changes made in respect of the safety database
Input and authority (where required) over the Risk Management Plan (RMP) and
awareness of Marketing Authorisation (MA) conditions/obligations/commitments relating to
safety/safe use, including risk minimisation measures
Oversight of on-going/completed clinical trials and other studies conducted by the company or partners
Responsible for inbound safety-related information from affiliates and contractual
partners
Author and implement procedures (at every level) relevant to the pharmacovigilance system and fulfilment of pharmacovigilance related commitments
Update and implement the PV Quality Management System (QMS), including,
routine compliance metrics (PSUR/ICSRS), contributing to CAPA plans arising from
pharmacovigilance-related audits and inspections and overseeing the quality of PV data

The ideal candidate must have 6 years + experience Pharmacovigilance experience in the Pharmaceutical industry.

For further information on this QPPV position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie.
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