30 days old

Safety Risk Lead (SRL)

Pfizer
Hedgesville, WV 25427
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**ROLE SUMMARY**



+ 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.



**ROLE 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

+ 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 WMS/PSSR 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

+ Frequently independently performs evaluation of all sources of safety data, identifies and independently analyzes safety signals, and presents evaluation of safety signals and benefit risk assessments to the appropriate forums

+ Contributes SSRM perspective and subject matter expertise to all relevant areas of risk management plans, expert reviews, Health Authority Queries and other documents as required

+ Prepares basic action plans independently to address risk and benefit-risk issues. Handles more advanced/complex plans with direction/coaching

+ Conducts and Represents SSRM on due diligence activities.

+ Provides guidance and/or oversight to SSRM colleagues on safety issues.Provides formal and informal education to other SSRM colleagues on key safety and pharmacovigilance topics

+ Represent WSS on safety and benefit-risk issues to external groups including regulatory authorities and business partners

+ Contributes to review and development of intradepartmental policies and procedures as appropriate

+ Initiates, conducts and chairs Risk Management Committee, P-BRC (co-chair) and CWGs with minimal oversight

+ Prepares and contributes to written safety assessments and benefit-risk evaluations

+ Reviews safety assessments/evaluations/contributions prepared by senior manager SRLs and other safety colleagues

+ Completes all assigned activities with minimal guidance.

+ 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



**QUALIFICATIONS**



+ Education: MD (physician) degree required

+ Minimum 5 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

+ Rare Diseases and/or Oncology Disease Area specific knowledge is preferred, including understanding of early 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



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



Standard travel and working flexible hours can be required ad-hoc.



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Medical



\#LI-PFE
Posted: 2021-06-24 Expires: 2021-07-25
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Safety Risk Lead (SRL)

Pfizer
Hedgesville, WV 25427

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