Drug Safety Unit Cluster Lead

Position Purpose

Lead, manage and provide strategic direction to the pharmacovigilance teams of the countries within the Cluster.

Accountable for all strategic phv activities for the countries within the Cluster.

Support Regional and Global level Safety projects.

Oversight of all cluster activities relevant to the pharmacovigilance system to ensure monitoring of the safety profile of Pfizer products and to meet regulatory requirements. Manage resources in the cluster.

Primary Responsibilities

Leadership and Strategic Role

Lead and manage the Cluster along with the Country Safety Lead role.

Responsible for the leadership, development, and performance management of the Country Safety Leads (CSLs) 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.

Sets objectives for and manages multiple projects/ ongoing work activities of high complexity within the Cluster. Manage and Co-ordinate work-sharing within cluster. Strategic management of Cluster resources in collaboration with platform and WWS leadership.

Provides guidance to CSLs for projects/decisions impacting safety reporting at country level. Engage and provide guidance to the CSL network.

Engages in cluster level network with functions beyond safety (e.g.: quality, CEPs etc).

Partner with safety and non-safety functions in regional/global projects to provide expertise and contribution.

Support CSLs to engage the PCO network.

Uses knowledge of industry, customer requirements and general business environment to adapt and implement strategic actions.

Exhibits a high level of business knowledge and understanding of the external marketplace, business line or other internal business partners requirements.

Champions innovation and compliance.

Develops and leverages resources to implement innovative ideas, processes, across Cluster.

Consider thoughtful risks to achieve results without compromising regulatory compliance.

Operational Excellence

Ensure fulfilling of drug safety and medical device related obligations for the countries in the cluster in compliance with Pfizer standards and international/local regulations.

Support timely and accurate handling of individual and aggregate reports to meet corporate and regulatory reporting requirements for the cluster.

Ensure timely handling of local safety issues; support the Country Safety Lead in managing local safety issues in collaboration with central safety functions and the local stakeholders.

Support the timely handling of local safety-related regulatory requests, in co-operation with the Country Safety Lead

Maintain expertise in cluster as well as worldwide regulations and guidelines and promote increased awareness of the legislative and regulatory environment in the cluster.

In the absence of the Country Safety Lead, act as point of contact for the countries in the cluster, internally and externally

Ensure Business Continuity Plan across the Cluster is in place; promote business continuity culture.

Develop and maintain knowledge of applicable Corporate Policies, SOPs, WI, and other procedural documentation.

Conduct recruitment of CSL positions as needed.

Monitor the effective rollout of new processes across the cluster.

Effectively collaborate with Regional Platforms and CT HUB to manage workload, as well as relevant Centers of Excellence, as needed.

Actively participate in WWS and relevant townhalls, meetings, surveys, knowledge sharing.

Continuous improvement of quality culture and inspection readiness

Impact pharmacovigilance and patients safety in external environment by engagement in industry associations, scientific societies, Working Groups etc.

In cooperation with the Country Safety Lead:

Organize and manage the cluster safety groups to ensure effective coverage of safety-related activities.

Provide guidance to the cluster for standardization of processes and goals.

Facilitate resolution of concerns and questions in the cluster

Mentor colleagues in the cluster on the effective use of the corporate safety database

Ensure offices in the countries are inspection-proof and ready.

Ensure and monitor implementation of corrective actions resulting from timeliness or quality issues associated with safety-related activities for the countries in the cluster.

Provide oversight for the standardization and quality of local safety data exchange agreements.

Assist Country Safety Leads with recruitment, training, coaching, and mentoring of relevant country team.

Ensure transition plans incountry as needed.

Fully utilize corporate tools, to manage the performance reviews of assigned colleagues in the cluster.

Represent Pfizer pharmacovigilance in local industry associations and other external groups, where appropriate

Promote local, internal, and external safety activities in collaboration with the Country Safety Leads and internal and external stakeholders.

Technical Skill Requirements

Management of ex-country units

Good understanding of computer technology and demonstrated computer literacy particularly in use and management of relational databases.

Knowledgeable in pharmacovigilance regulations and 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.

Qualifications (i.e., Preferred Education, Experience, Attributes)

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.

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