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Pfizer Safety Team Lead in Hospira, India

Active contribution to activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile of Pfizer products and to meet regulatory requirements. Back-up contact point in the country, internally and externally, for all safety-related aspects. Supports resource management in the country. Primary Responsibilities

Support the CSL in fulfilling drug safety-related obligations for the country

• Participate in above-country activities as DSU representative, as required by CSL

• Ensure timely and accurate handling of individual and aggregate reports to meet corporate and regulatory reporting requirements for the country

• In collaboration with the CSL, ensure timely handling of local safety issues, manage local safety issues in collaboration with central safety functions and relevant stakeholders, as required

• Support the timely handling of local safety-related regulatory requests

• Maintain expertise in country as well as worldwide regulations and guidelines

• Promote increased awareness of the legislative and regulatory environment in the country

• Deputise for the CSL, as requested, in the promotion of local, internal and external safety activities, in collaboration with the relevant 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

• Support the CSL in organizing and managing the country safety group to ensure effective coverage of safety-related activities

• Develop and maintain knowledge of applicable SOPs and other procedural documentation

• Provide guidance for standardization of processes and goals

• Manage and monitor the effective rollout of new processes

• Facilitate resolution of concerns and questions

• Mentor colleagues on the effective use of the corporate safety database

• Support the organization and management of inspection readiness activities

• Support the implementation of corrective actions resulting from timeliness or quality issues associated with safety-related activities for the country

• Support the standardization and quality of safety data exchange agreements

• In collaboration with the CSL, monitor and manage training of DSU members, and ensure coaching and mentoring

Support effective recruitment for the DSU; fully utilize corporate tools to manage the performance reviews of assigned colleagues in the country

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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