Country Safety Lead, Dubai - Pfizer

Reports to North West Africa and middle east Cluster Safety Lead (CL)

Position Purpose

• 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 Role
Lead 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 Partnerships

Develop strong partnerships within the country (e.g. Country Managers, Medical, Marketing), and above-country functions

Participate 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/councilsParticipate 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 Excellence

Ensure 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:
• Effectively 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 culture
• Participate in global/regional project and working groups, if needed.
•  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
• 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 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
• 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
•  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 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

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

• Degree / Advanced degree in pharmacy , 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

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