Deputy European Union

Há 4 dias


Lisboa, Lisboa, Portugal Tn Portugal Tempo inteiro

.Social network you want to login/join with:Deputy European Union (EU) Qualified Person for Pharmacovigilance (m/f/d), LisbonClient: LillyLocation: Lisbon, PortugalJob Category: OtherEU work permit required: YesJob Reference: 2fe7b2fe448fJob Views: 22Posted: 23.01.2025Expiry Date: 09.03.2025Job Description:We're looking for people who are determined to make life better for people around the world.
Interested?
Then become part of our team and start as soon as possible as:Deputy European Union (EU) Qualified Person for Pharmacovigilance (m/f/d)What challenges await you?Deputise for the European Union QPPV as required and according to delegation and specifically to fulfil the legal and regulatory requirements for the QPPV role in his or her absence.Provide strategic and technical pharmacovigilance advice to Global Patient Safety (GPS), and other regulatory and medical functions within the Medicines Development Unit.Play an active role in the GPS Leadership Team, Safety Review Committee (SRC) and other committees as required.Provide training /coaching /mentoring and demonstrating Global Patient Safety expertise and leadership.Deputise for the EU QPPV on the Global Product Labelling Committee (GPLC) as required.Primary Responsibilities:Fulfil the legal and regulatory requirements for the EU Qualified Person responsible for pharmacovigilance role as defined by prevailing European legislation and guidelines in the absence of the EU QPPV or as delegated by the EU QPPV.Ensure appropriate cover with the QPPV including provision of all the necessary information to fulfill the role.Maintain current awareness of the evolving EU regulatory environment, provide timely feedback to GPS leadership, and provide advice to the Medicines Quality Organisation as appropriate.Review and provide expert input to EU regulatory submissions PASS protocols and actions taken in response to emerging safety concerns.Provide QPPV input to GPLC in the absence of the QPPV or as delegated.Fulfill all other QPPV obligations as stipulated in the Good Vigilance Practice (GVP) guidelines as delegated by the QPPV.Play an active role in the GPS Leadership Team, SRC and other committees including GPLC as appropriate.Provide an independent expert viewpoint on specific safety issues.Maintain links with Global Regulatory Affairs and provide technical consultancy to safety sections of European regulatory submissions.Provide technical leadership through active external involvement in pharmacovigilance forums.Provide training, coaching and mentorship to safety surveillance scientists, and other Global Patient Safety Medical physicians and clinical research scientists.Participate in recruitment and succession planning activities and provide advice regarding potential candidates as requested



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