Drug Safety Manager
Lead, manage and provide strategic direction to the country pharmacovigilance teamAccountable for all strategic product safety activities for the countryServe as point of contact of Pharmacovigilance Business Line as well as safety-related issues internally and externallyActive contribution to the activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile of Pfizer products and to meet regulatory requirements.
Act as a local Qualified Person for Pharmacovigilance (QPPV) or local responsible / contact person for Drug Safety related matters when required by local regulations.
Reports to Drug Safety Regional Head
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 QPPV, taking part and cooperating with the Global QPPV office and being an active member of the respective QPPV council.
Manage local system 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 countrySupport local, internal and external safety activities in collaboration with internal and external stakeholdersAct as a representative of Global Pharmacy Office and be an active member of the medical committees / councils for pharmacy operations.
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 pharmacovigilance strategies or the business.
Work with related authorities for advice / clarification if regulatory position is unclear and answers are not available through internal network.
Respond to spontaneous requests from authorities and collaborate with the local Pharma Association and the authorities in order to impact pharmacovigilance standards in country.
Ensure internal regulatory and pharmacovigilance processes and procedures are well documented and support compliance and regulatory activities.
Efficient and high-quality execution of safety-related activitiesPerformance towards corporate functions and local compliance towards regulatory bodiesEfficient management of resources in the Drug Safety Unit (DSU).
Advanced Degree or Degree Holder in medicine, life sciences or related disciplines6-8 years of experience in the pharmaceutical industry, with solid experience in pharmacovigilance, clinical research or product development are required.
Possess professional knowledge of national or regional regulatory legislation and guidelinesGood problem solving and decision-making skillsStrong Leadership and interpersonal skillsExcellent communication and negotiation skillsHighly skilled in time management and change management, organizational and facilitation skillsAbility to meet the objectives to drive departmental standards of performanceCandidates with less experience will be considered as Manager position
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