European Safety Office

2 weeks ago

Ljubljana, Ljubljana, Slovenia Pfizer Full time €90,000 - €120,000 per year
Pfizer is hiring a European Safety Office Medical Senior Manager

Primary Responsibilities
  • Keep permanently updated on EU Pharmacovigilance regulations and policies.
  • Ensure support the EUQPPV and Deputy in fulfilling safety qualified person obligations in Europe.
  • Support the activities of WMS, as appropriate, including development of relevant processes and practices, with particular reference to European Directives, Guidance and Points to Consider.
  • Ensure support to the EUQPPV in the monitoring of compliance (time and quality) for expedited individual and aggregated data reporting, of product issues (including recalls), and of overall performance as regards safety in Europe.
  • Partner with relevant functions to ensure the monitoring of cumulative safety data for products approved in Europe as well as products in development with intent to register, and to support safety signal generation and evaluation activities, in one or more specific therapeutic area(s) of responsibility.
  • Participate directly or via a designee to Risk Management Committees and benefit/risk governance bodies as required.
  • Partner with relevant functions to support and ensure the appropriate and timely delivery of high quality aggregated data reports and other regulatory documents for European Health Authorities, in compliance with European requirements, for all products within the therapeutic area(s) of responsibility.
  • Ensure the timely and quality review of aggregate data reports, safety data exchange agreements, labelling (Core Data Sheet and, for CAP and MRP products, SmPC), pharmacovigilance and risk management plans, and other documents (e.g. protocols for post-authorisation safety studies, study reports).
  • Partner with relevant functions to support the definition and update of product safety profiles and labelling in Europe.
  • Support the functions responsible for submission of individual reports to the EudraVigilance database.
  • Globally monitor all safety related matters potentially impacting on Europe.
  • Collaborate with the safety functions within WMS, as well as other departments, as appropriate, to ensure effective collaboration on all European issues.
  • Represent PFE at drug agencies in Europe where required.
  • Support the PFE country-based safety units as regards pharmacovigilance aspects of European relevance.
  • Support the monitoring of the status of PFE products in Europe, including commitments, and the monitoring of the evolution of the European regulatory/methodological/ philosophical approaches to drug safety.
  • Maintain the documentation systems pertaining to the EUQPPV activities.
  • Selection of adequate personnel, and their training in pharmacovigilance and relevant processes and procedures.
  • Ensure that each role in the function has an adequate job description.
  • Ensure that policies and procedures are in place and maintained to guarantee quality and timeliness of deliverables.

Qualifications
  • Medically qualified (MD certification or equivalent). Higher medical degree or specialization, experience in clinical research preferred, experience in epidemiology preferred.
  • Sound medical knowledge.
  • Previous experience in the pharmaceutical industry in pharmacovigilance or clinical research departments on an international level.
  • Good understanding of computer technology, and management of relational database systems.
  • Fluency in written and verbal English. Working knowledge of at least one other European language preferred.

Technical Skill Requirements
  • Expertise in medical aspects of pharmacovigilance, scientific basis for therapies and drug-induced diseases.
  • Understanding of pharmacovigilance internal and external environment, including scientific, methodological and regulatory aspects with a special focus on European requirements.
  • Understanding of product development and clinical research.
  • Demonstrated ability to analyze, frame, and communicate complex issues and their strategic implications for patient safety, including scientific writing and presentation proficiency.
  • Ability at operating in a matrix environment.
  • Good oral and written communication and presentation skills.
  • Good communication and negotiation skills with internal and external parties.
  • High skills in time management and organization.

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