Pfizer

Safety Risk Lead, Sr. Manager

Posted 2 Days Ago

Be an Early Applicant

2 Locations

Hybrid

Senior level

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

The Safety Risk Lead, Sr. Manager is responsible for safety surveillance, risk management, and communication on safety matters across Pfizer's product portfolio while providing expertise in pharmacovigilance and leading cross-functional teams.

Summary Generated by Built In

Position Purpose

Performs proactive safety surveillance and risk management to effect product safety signal detection & evaluation, risk assessment and safety risk minimization
Works with other Pfizer functions engaged in benefit-risk management (Regulatory Affairs, Quality, CMO, Corporate Audit, etc) to enable one medical voice
Articulates clear and informed medical judgement to enable sound business decisions and to enable productive engagement with health authorities.

Primary Responsibilities

Act as a point of contact for Safety in the Asset Teams, ensuring a unified communication on safety matters and representing WWS position(s) on safety
Chairs RMCs and Core Working Groups for his/her assigned products with oversight
Represents Pfizer WWS at internal (e.g. governance and business unit disease area leadership teams) and external forums (e.g. regulatory authority and business partner interactions) as agreed with Manager
Evaluates safety data of any source with oversight, identifies and analyzes safety signals, and presents medical evaluation of safety signals and benefit-risk assessments to the appropriate forums
Provides disease area specific pharmacovigilance expertise, and applies this to various business unit products assigned to him/her
Assists with preparation of basic action plans to address risk and benefit-risk issues, often requiring cross-functional activity to address safety issues and risk minimization plans
Prepares and contributes to written safety assessments and benefit-risk evaluations
Reviews and approves, as appropriate, safety documents including those pertaining to the B-R profile of Pfizer's products
Ensures consistency of safety risk messaging for a particular product or class of products, across multiple indications/BUs. Represents SSRM on due diligence activities
Identifies opportunities for consistency and standards for safety surveillance and risk management processes
Innovates, champions and implements novel approaches to safety surveillance and risk management across Pfizer's portfolio of products: engages in continuous improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements
Engages in inspection readiness support including provision of data to project managers for metrics and activity tracking
Develops a culture of courage, excellence, equity and joy within the team including regular communications, coaching, and mentoring of the team as required.

Technical Skill Requirements

Medical Degree or equivalent.
Oncology background preferred not required.
Understanding of aggregate safety data and signal assessment methodology, and ability to perform benefit-risk assessments
Ability to perform safety data review, safety data assessment, Clinical safety signal identification, risk identification and risk management
Understanding of the scientific basis for therapies and drug-induced diseases
Ability to lead a cross functional team and lead through example, commitment and enthusiasm in a matrixed environment with minimal oversight
Strong scientific and medical knowledge, including fluency in the medical literature
Ability to integrate data to support benefit/risk decision-making
Understanding of statistics and analytical tools
Knowledge of global safety/regulatory issues and concerns as they relate to the business or clinical research-based compound development
Effective verbal and written communication skills.

Work Location Assignment: Hybrid
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
Medical

Top Skills

Benefit-Risk Assessments

Clinical Safety Signal Identification

Risk Identification

Risk Management

Statistical Tools

What the Team is Saying

View all jobs at Pfizer

View Pfizer Profile

Report Job

Am I A Good Fit?

beta

Get Personalized Job Insights.

Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.