Pfizer Safety Risk Lead (SRL) in Collegeville, Pennsylvania
The Safety Risk Lead (SRL) will perform proactive Safety Surveillance (SS) and Risk Management with focus on signal detection and evaluation, risk assessment and safety risk minimization.
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
Provides disease area specific pharmacovigilance expertise , and applies this to various business unit products assigned to the SRL operating from a SSRM DA-Cluster. Each SSRM DA-Cluster functions as a "Centre of Excellence"
Ensures consistency of Safety Risk Messaging for a particular product or class of products, across multiple indications/BUs within the many safety reports and communications for that product. Providing suitable summaries of product risks to summary document authors where appropriate, for example providing medical content/B-R statements and overall risk messaging of the safety profile to WSR/SER Authors
Performs ad hoc special scholarly Safety Surveillance & Risk Management activities, rapidly, to meet specific needs in the BUs, such as RRT deliverables/emerging safety issue white papers/product Due Diligence Assessments
Identifies opportunities for Consistency and Standards for Safety Surveillance & Risk Management approaches and processes within a DA-Cluster and across BUs, and supporting the piloting and implementation of such
Innovates, champions and implements novel approaches to Safety Surveillance & Risk Management across BUs: engages in Continuous Improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements
Engages in inspection readiness and support. Provision of data to project managers for metrics and activity tracking.
Fully independently evaluates complex safety data of any source, identifies and independently analyzes complex safety signals, and presents medical evaluation of safety signals and complex benefit-risk assessments to the appropriate forums
Contributes SSRM perspective and advanced subject matter expertise to all relevant areas of risk management plans, expert reviews, Health Authority queries and other documents as required
Prepares advanced/complex action plans to address risk and benefit-risk issues, often requiring cross-functional activity to address safety issues, including complex Risk Management activities
Conducts and Represents SSRM on complex due diligence activities. Coaches others in due diligences
Provides guidance and/or oversight to any team member on safety issues. Provides formal and informal education to other SSRM and team colleagues on key safety and pharmacovigilance topics. Coach others in PV/RM.
Represents WWS on safety and benefit-risk issues to external groups including regulatory authorities and business partners
Contributes to intra- and interdepartmental policies and procedures and plans for the implementation of new policies and procedures
Independently initiates, conducts and chairs RMC, P-BRC (chair) and CWGs
Prepares and contributes to written complex safety assessments and advanced benefit-risk evaluations.
Reviews safety assessments/evaluations/contributions prepared by other SRLs and safety other colleagues.
Independently prioritizes and completes all activities including multiple complex activities
Makes decisions based on clinical experience.
Utilizes knowledge of integrated body systems' pathophysiology to evaluate the impact of product issues
Assesses the suitability of biopharmaceutical products on typical physician practice within various health systems, hospital and non-hospital patient care facilities
Ensures products fulfil quality medical care
For early development programs serve as a safety consultant to Clinical
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Education: MD (physician) degree required
Minimum 7 years of: medical (e.g. patient care, clinical trial experience/investigator, academic medicine, specialty training and/or board certification), and/ or scientific, and/or pharmacovigilance or and/or drug development experience required
Oncology Disease Area specific knowledge is preferred, including understanding of Oncology drug development
Thorough understanding of Safety Risk Management internal and external environment, including applicable regulations and guidances
Clinical development and post-marketing experience to have an understanding of safety context across the drug lifecycle
Demonstrated leadership in day-to- day activities and collaborative skills
Demonstrated self-awareness and interpersonal skills for successful execution of the role
Demonstrated ability to handle more than one complex project simultaneously, prioritizing well and recognizing key issues
Ability in, and track record of, working effectively in an advanced matrix structure, including matrix team leadership/representation preferred
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
Relevant knowledge of Pharmaceutical Company organizational structure, policies, and practices, as applicable to safety Risk Management
Technical Skills, (plus knowledge, experience and ability in):
Safety data review, Safety data assessment, Clinical Safety signal identification, risk identification and risk management. Understands aggregate safety data and signal assessment, and performs benefit-risk assessments. From a medical perspective, independently evaluates safety data, identifies and independently analyzes safety signals, and presents the medical evaluation of safety signals to the appropriate forums
Matrix safety team leadership
Understanding of the scientific basis for therapies and drug-induced diseases. Effective interactions with key external subject matter experts including regulatory authorities
Disease Area specific knowledge is preferred (Anti-Infectives; Internal Medicine)
Thorough understanding of Safety Risk Management internal and external environment, including applicable regulations and guidances.
Clinical development and post-marketing experience to have an understanding of safety context across the drug lifecycle.
Relevant knowledge of Pharmaceutical Company organizational structure, policies, and practices, as applicable to safety Risk Management.
Other Job Details:
Last Date to Apply for Job: February 15th, 2022
Additional Location Information: New York, NY; Collegeville, PA; Groton, CT; Peapack, NJ; UK - Walton Oaks; UK - Sandwich
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & 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, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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