Pfizer Israel in Herzliya Pituach, Israel
Pfizer Israel is looking for a Country Safety Lead.
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.
Reports to Head of GPO or Drug Safety Unit Regional Head (DRH) or Cluster Safety Lead
May act as Qualified Person of Pharmacovigilance.
Primary Responsibilities :
Efficient, high-quality execution of safety-related activities
Performance towards corporate functions and local compliance towards regulatory bodies
Efficient management of resources in the Drug Safety Unit (DSU). In detail:
Ensure fulfilling of drug safety-related obligations for the country
Where required by regulations, act as local contact or local QP PV
Participate in country activities as DSU point of contact for Pharmacovigilance Business Line
Ensure timely and accurate handling of individual and aggregate reports to meet corporate and regulatory reporting requirements for the country
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
Manage and monitor the effective rollout of processes
Facilitate resolution of concerns and questions
Mentor colleagues on the effective use of the corporate safety database
Organize and manage inspection readiness activities in the country
Take responsibility for implementing corrective actions resulting from timeliness or quality issues associated with safety-related activities for the country
Support the standardization and quality of local safety data exchange agreements
Monitor and manage training of DSU, and ensure coaching and mentoring
Organize and manage recruitment for the DSU; fully utilize corporate tools, to manage the performance reviews of assigned colleagues in the country
Manage and monitor cost of the country team and relevant safety activities
Technical Skill Requirements:
Knowledgeable in pharmaceutical business, including drug development and regulatory aspects
Good understanding of medical and scientific terminology
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.