Pharmacovigilance Physician

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Job Description

Our client, a global pharmaceutical company are currently recruiting for a Pharmacovigilance Physician. This is  permanent, full-time role.

 

Provide medical evaluation and support for the Pharmacovigilance operations of all products.

 

The PV Physician (PVP) will be responsible for the medical evaluation of all company products/projects, and will work with the QPPV/Deputy QPPV and other PV Physicians to ensure that medical support is always available within the PV Department. The PVP 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, prioritizing and evaluating safety signals, writing the safety section of the electronic CTD (common technical document), providing safety input to company project teams as required, producing scientific reports on specific safety issues, and responding to queries (both internal and external) regarding safety issues. The PVP will be responsible for providing medical input to the Risk Management Plans and performing maintenance activities on assigned products.

Duties:

  • 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
  • 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

Safety:

  • Provide safety triage of all incoming adverse event reports
  • Medically review adverse event reports, including literature reports
    • Assessment of seriousness, expectedness & causality
    • Perform the medical evaluation of the aggregate, global safety data
  • Request and evaluate follow-up and/or additional information
  • Make decision to unblind SUSARs in clinical studies
  • Interpret data from literature, clinical studies, lab results etc. in the light of the benefit/risk profile of company products
  • Perform medical review and providing input/writing to the PSUR/PBRER, DSUR, ASR and Clinical Expert Statements
  • Conduct medical review and provide input/writing to the Risk Management Plans (RMPs), and together with the PV Scientist co-ordinate their production and maintenance
  • Responsible for the timely communication to the QPPV in case of safety issues and contribute to the initiation and coordination of all appropriate actions in accordance to applicable policies and SOPs

Training:

  • Mentor and provide support to new PV Physicians and PV Scientists
  • Provide ongoing medical training and support as required to colleagues

Requirements:

  • Medical Degree
  • At least 1-2 years of clinical practice
  • Good working knowledge of clinical medicine
  • Knowledge of principles of epidemiology and statistics
  • Microsoft Office
  • Awareness of competitor products and activity
  • 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
  • Pharmacovigilance practice and procedure
  • EU Competent Authorities and Regulations
  • Marketing Authorisation rules and regulations
  • Working knowledge and familiarity with clinical protocols, clinical study reports

For a full Job Spec and to apply for this role please call Linda on +353 1 2784671 or e-mail LDunne@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671

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Tina Dunne

Recruitment Manager 01 2784671 tdunne@thornshaw.com
  • Salary:Negotiable
  • Location:West Dublin
  • Type:Permanent
  • Category:Science,Thornshaw
  • Ref.no:JO-2003-448494_24