Lead, manage and provide strategic direction to the country pharmacovigilance team.
Accountable for all strategic PV activities for the country(ies).
Serve as point of contact of Pharmacovigilance Business Line for the PCO.
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.
When required by local regulations act as a local QPPV or local responsible/contact person for PV.
Primary Responsibilities Leadership and Strategic RoleLead and manage the country team.
Ensure that the team provides input into global and regional strategies to provide optimal support for meeting regional and country business objectives.
Responsible for the leadership, development, and performance management of the country team to achieve company objectives and culture. Develop and enhance the capabilities and capacities of the team through the identification and implementation of training and development needs.
Where required by regulations, act as local contact or local QP PV, taking active part and cooperating with the Global QPPV office and being active member of the respective QPPV council. Manage local PSMF or equivalent document as needed.
Maintain expertise in country as well as worldwide regulations and guidelines and promote increased awareness of the legislative and regulatory environment in the country
Internal PartnershipsDevelop strong partnerships within the country (e.g. Country Managers, Medical, Marketing), and above-country functionsParticipate in country activities as DSU point of contact for Pharmacovigilance Business Line
Act as country?s point contact for Safety, internally and externally
Support local, internal and external safety activities in collaboration with internal and external stakeholders
Represent GPO and be an active member of the local PCO medical committees/councils Participate in CMF, Quality Forum, Compliance Committee and similar local groups as needed.
External Relationships
Represent Pfizer pharmacovigilance and actively participate in local Pharma Association(s) and other external groups, and effectively communicate to key stakeholders of key issues that could impact PV strategies or the business.
Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network. Respond to spontaneous requests from authorities Acting within the local Pharma Association collaborate with authorities in order to impact pharmacovigilance standards in country.
Operational ExcellenceEnsure internal regulatory/PV processes and procedures are well documented and support compliant regulatory/PV activities.
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 in compliance with Pfizer standards and international/local regulations.Ensure timely and accurate handling of individual and aggregate reports to meet corporate and regulatory reporting requirements for the countryEnsure timely handling of local safety issues; manage local safety issues in collaboration with central safety functions and local stakeholdersSupport timely handling of local safety-related regulatory requestsMonitor, 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 activityMonitor 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 activityEffectively collaborate with Regional Platforms and CT HUB to manage workload, if needed.Actively participate in WWS and other safety/medical townhalls, meetings, surveys, knowledge sharing.Continuous improvement of quality cultureParticipate in global/regional project and working groups, if needed.Organize and manage the country safety group to ensure effective coverage of safety-related activitiesDevelop and maintain knowledge of applicable SOPs, CP and other procedural documentationProvide guidance to the country group for standardization of processes and goalsManage and monitor the effective rollout of processesFacilitate resolution of concerns and questionsMentor colleagues on the effective use of the corporate safety databaseOrganize and manage inspection readiness activities in the countryTake responsibility for implementing corrective actions resulting from timeliness or quality issues associated with safety-related activities for the countrySupport the standardization and quality of local safety data exchange agreementsMonitor and manage training of DSU, and ensure coaching and mentoringOrganize and manage recruitment for the DSU; fully utilize corporate tools, to manage the performance reviews of assigned colleagues in the countryManage and monitor cost of the country team and relevant safety activitiesTechnical Skill Requirements
Knowledgeable in pharmaceutical business, including drug development and regulatory aspects
Good understanding of medical and scientific terminology in both local language and English
English Proficiency
Knowledge and understanding of quality aspects, processes, audit and inspections.
Good understanding of computer technology and demonstrated computer literacy particularly in use and management of relational databases
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
In depth knowledge of national/regional regulatory legislation and guidelines
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
Ability to manage/oversee in country and ex-country pharmacovigilance partners
Work Location Assignment:Flexible#LI-PFEPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Medical#LI-PFE
