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PV Physician Manager

Ref: 9221399

  • €95,000 - €110,000
  • 13 May 2020
  • Dublin (West)
  • Perm

Brightwater has been retained in the search for a PV Physician Manager to provide medical evaluation and support for the Pharmacovigilance operations of all products across affiliate companies for which marketing authorisations are held. The PV Physician Manager (PVP Manager) will be responsible for the medical evaluation of all products/projects, and will work with the QPPV/Deputy QPPV and other PV Physicians to ensure that medical support is always available within the APTL PV Department. The PVP Manager will be responsible for medical evaluation of Individual Case Safety Reports (ICSR), Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Report (PSUR/RBRER), Annual Safety Reports (ASR), and other safety reports as required. The PVP will be responsible for detecting, prioritising and evaluating safety signals, writing the safety section of the electronic CTD (common technical document), providing safety input to project teams as required, producing scientific reports on specific safety issues, and responding to queries (both internal and external) regarding safety issues. The PVP Manager will be responsible for providing medical input to the Risk Management Plans and performing maintenance activities on assigned products.

Overview:

• Expectation of delegated tasks from QPPV on a defined and ad hoc basis with flexibility of mind-set and time resource that this entails. This will include representation at meetings when required. • Identify, evaluate and manage risks for Risk Management Plans (RMPs) and ensure their timely completion in cooperation with the PV Scientist • Provide medical/scientific support to PV Scientist • Assist the QPPV/Deputy QPPV in evaluating evidence or information to determine whether a ADR/AE/Quality Defect or similar necessitates a possible Product Withdrawal or Product Recall • Support PV functions particularly analysis of data relating to vendors, consultants and contractors • Provide input as required for Safety Data Exchange Agreements • Author/review DHCP and other safety-related communications • Participate in PV audits and inspections as required • Contribute to compliance monitoring and quality control of case processing as required • Provide support to related PV activities such as preparation of reports for surveillance support, collating reports for review of product quality data, support of health hazard evaluations, scientific presentations etc. • Participate in preparation, analysis and writing of ad-hoc and aggregate regulatory reports and labelling support documents, particularly providing medical input • Medical review of ICSR, including evaluating the need for follow-up requests • Ensure Good Documentation Practice • Maintain awareness of Pharmacovigilance regulatory requirements and developments • Contribute to agreed PV Team compliance targets • Serve in a leadership capacity for complex and strategically important Pharmacovigilance developmental programs

Job related work experience required:

• Medical Degree • At least 1-2 years of clinical practice • Documented experience in pharmacovigilance • Experience in medical evaluation of ICSR, including literature review • Experience evaluating potential safety signals • Experience providing medical input to safety reports (PSUR/PBRER, ASR) and Risk Management Plans • Experience responding to safety-related queries from Competent Authorities • EU Competent Authorities and Regulations • Marketing Authorisation rules and regulations

Benefits:

• Highly competitive salary • Healthcare • Pension • Bonus To apply for this PV Physician Managers role, click the “Apply Now” button or for more information, please contact Marc Bentley on 01 662 1000 or email [email protected]