Regional Safety Lead – US & Canada

Pfizer • New York City, NY

1d • Hybrid

About The Position

The primary objective of the Regional Safety Lead is to contribute to the surveillance of the safety profiles of Pfizer products, both under development and marketed, for all therapeutic areas, by ensuring efficient and compliant case intake and reporting operations. This is an above country, regional function. The Regional Safety Lead has organizational and management responsibility for Worldwide Safety (WWS) staff and activities in the Canada and US Drug Safety Units (DSUs) to ensure fulfillment of human safety-related obligations for the Company products, either marketed or investigational, at corporate and local level.

Requirements

• Knowledgeable in national (US and Canada), international pharmacovigilance regulations and worldwide reporting requirements.
• Knowledgeable in pharmaceutical business, including drug development and regulatory aspects
• Good understanding of pharmacovigilance database(s), entry conventions, and workflow requirements
• Good understanding of medical and scientific terminology
• Advanced degree in medical sciences such as Pharm D, Master’s, PhD
• Minimum of 5 years management experience, preferably of teams in multiple locations
• Minimum 10 years' experience in the pharmaceutical industry in pharmacovigilance or clinical research or product development
• Ability to operate in complex systems and organizations.
• Ability to manage/oversee in country and ex-country pharmacovigilance partners
• In depth knowledge of national/regional regulatory legislation and guidelines
• Highly skilled in time management and change management, organizational and facilitation skills.
• This position requires permanent work authorization in the United States.

Responsibilities

• Accountable for strategic PV activities for the Canada and US DSUs
• Ensure that the Canada and US DSUs provide 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 Canada and US DSU teams to achieve company objectives and culture.
• Partner with safety functions and non-safety function in regional/global projects to provide expertise and contribution.
• Direct, mentor, and manage the performance of the Country Safety Team Leads and other direct reports to foster a high-performance culture aligned with corporate values.
• Maintain expertise in region as well as worldwide regulations and guidelines and promote increased awareness of the legislative and regulatory environment in the countries
• Champions innovation and compliance
• Execute pharmacovigilance related activities with high-quality and efficiency.
• Ensure fulfilling of drug safety and medical device related obligations in Canada and the United States in compliance with Pfizer standards and international/local regulations.
• Support the timely handling of local safety-related regulatory requests with the Country Team Lead.
• Ensure timely handling of local safety issues; support the Country Team Lead in managing local safety issues in collaboration with central safety functions and local stakeholders.
• Responsible for identifying and driving process improvement/continuous improvement around areas of direct responsibility.
• Participate in appropriate committees including WWS leadership team, WWS policy committee, CCIC COQ (Commercial Customer Interaction and Communication Quality Oversight Committee)
• Responsible for ensuring adverse event reporting case operations teams within the DSUs are following applicable regulations.
• Facilitate effective communication within the team, with other Safety colleagues and with internal and external stakeholders, to assure that all issues are effectively surfaced for resolution.
• Ensure fulfilment of human pharmacovigilance and safety-related obligations for the Company products, marketed or investigational.
• Ensure appropriate communication of safety topics to and from the DSUs.
• Collaborate with regional and corporate counterparts.
• Lead in the design, development and implementation of state-of-the-art processes and training for document preparation where necessary.
• Establish the goals, and manage the day-to-day performance, of the multi-functional team responsible for cross-functional efficient and compliant operations.
• Support acquisition integrations regionally
• Monitor and communicate to corporate, regional, national, and DSU level of legislative, regulatory and methodology changes.
• Communicate policy decisions and develop and monitor implementation plans at DSUs.
• Monitor the local regulations and guidance, ensure corporate awareness, and proactively address new requirements
• Partnering with other relevant functions to ensure the continuing upgrade and improvement of safety-related operations at country level, as required by evolving regulations and evolving internal policies and practices.
• Ensure inspection readiness and inspection success.
• Ensure subject matter expert (SME) availability and inspection training.
• Coordinate inspection preparation and conduct.
• Interact with regulators regarding inspection responses and process expectations.
• Address inspection and audit findings with root cause analyses, corrective and preventative actions (CAPA)

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior