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Country Safety Lead (m/f)
Location: Croatia - Zagreb
Type of contract: Temporary contract

Position Purpose

Active contribution to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile of Pfizer products and to meet regulatory requirements. Contact point in the country, internally and externally, for safety-related aspects.
Manage resources in the country.

Primary Responsibilities

  • Ensure timely handling of local safety issues; manage local safety issues in collaboration with central safety functions and local stakeholders
  • Support timely handling of local safety-related regulatory requests
  • Maintain expertise in country as well as worldwide regulations and guidelines and promote increased awareness of the legislative and regulatory environment in the country
  • Act as country's point contact for Safety, internally and externally
  • Represent Pfizer pharmacovigilance in local industry associations and other external groups
  • Support local, internal and external safety activities in collaboration with internal and external stakeholders
  • Monitor, and actively conduct as needed, local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency and any other required country-specific safety activity
  • Monitor and conduct as needed, local materiovigilance activities, including medical device incident monitoring and reporting as required by local agency, and any other required country-specific device safety activity
  • Organize and manage the country safety group to ensure effective coverage of safety-related activities
  • Develop and maintain knowledge of applicable SOPs, CP and other procedural documentation
  • Provide guidance to the country group for standardization of processes and goals

Technical Skill Required

  • Knowledgeable in pharmaceutical business, including drug development and regulatory aspects
  • Good understanding of medical and scientific terminology

Qualifications (i.e., preferred education, experience, attributes)

  • Degree / Advanced degree in medicine or in life sciences or equivalent experience
  • Several years of experience in the pharmaceutical industry in pharmacovigilance or clinical research or product development
  • Rational approach to issues and their business implications
  • Good problem solving and decision making skills
  • Team building and team management experience
  • Strong interpersonal skills, with a demonstrated ability to manage people and foster teamwork
  • Excellent communication and negotiation skills - ability to manage discussions and decision making across cultures
  • Highly skilled in time management and change management, organizational and facilitation skills
  • Ability to meet personal objectives while meeting departmental standards of performance
  • Comfortable working in a matrix environment

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



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