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Safety Risk Lead

Pfizer


Location:
Sandwich, MA
Date:
01/12/2018
2018-01-122018-02-12
Pfizer
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Job Details

**Primary Responsibilities**



Performs proactive Safety Surveillance (SS) and Risk Management (RM) to effect product safety signal detection, risk assessment and safety risk minimization.



Colleague capability (see separately available SRL capabilities and responsibilities continuum ) will drive Nature and Complexity of Assigned Responsibilities and Activities:







+ Safety Risk Leads (SRL) in SSRM may be assigned as the product "safety-management-team" (e.g. Risk Management Committee) Chairs and Asset (Product) Team safety representatives, flexibly supporting all BU/RUs. They will collaborate closely with the relevant WWS Safety Strategy Business Unit/Research Group Heads to support the appropriate BU safety strategies.







+ The SRL obtains guidance from the relevant WWS Safety Strategy Business Unit/Research Unit Leads to meet the BU/RU Safety Strategy goals.



+ SRLs may be assigned to act as a Safety Point of Contact to the Asset Teams, ensuring a unified communication on safety matters for WSR/WWS.







+ Providing and accumulating DA-specific pharmacovigilance expertise **,** and applying this to various BUs' products assigned to the SRL operating from a SSRM DA-Cluster. Each SSRM DA-Cluster functions as a "Centre of Excellence".



+ Performing frequent proactive Holistic Safety Review for products, across the span of relevant available safety data information. Reviews are incremental, cumulative and aggregate, to include the body of safety information available from WWS/WSRO and elsewhere (e.g. clinical, epidemiology, spontaneous, literature & regulatory cases, other scientific data).



+ Ensuring 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.



+ Performing ad hoc special scholarly SS & RM activities, rapidly, to meet specific needs in the BUs, such as RRT deliverables/emerging safety issue white papers/product Due Diligence Assessments.



+ Identifying opportunities for Consistency and Standards for SS & RM approaches and processes within a DA-Cluster and across BUs, and supporting the piloting and implementation of such.



+ Innovating, championing and implementing Novel Approaches to SS & RM across BUs: engagement in Continuous Improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements.



+ Platform for additional Centers of Excellence (e.g. Vaccines, Safety Advisory Councils, Contributions to or coordination of Other Pan-BU/RU activities).]



+ Engagement in inspection readiness and support. Provision of data to project managers for metrics and activity tracking.



+ Further;o Providing SS & RM support for a particular product, across the product's multiple use in different BUso Providing SS & RM support for a particular product in a BU, within and across the product's multiple indications in a BUo Leveraging DA focused expertise flexibly into all BUs, and deployment to Due Diligence in-licensing assessmentso Focuses intra- and inter- DA-Cluster sharing of information between related areas (e.g. safety knowledge of Pain vs Inflammation co-prescribing)o Enables "matrix assignment" from within SSRM to supporting WWS Group Heads.May work across more than one SSRM DA or DA-Cluster as appropriate to business need. The SRL may support product teams locally or globally (remote).May be assigned to chair/lead/support various Safety Management Teams (e.g. RMC and RMC CWGs etc.), on one or more products or group of products, for one or more Business Units.







(Note: "BU" used herein = BU/RU).







**Technical Skill Requirements:**







+ 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



+ Strong Matrix partnering, inclusiveness and collaborative working relationship with WSR/WWS colleagues, including engaging Safety Strategy Group Heads, Epidemiology Leads and other colleagues supplying sources of safety information. Actively engages WSR & WWS colleagues in RMCs and Asset teams as needed.



+ Effectively communicating resource, timeline and other issues that have e.g. regulatory impact, to the Group Heads.



+ Assisting with communication and knowledge transfer within and between SSRM DA Clusters, and across project/product teams.



+ Working effectively when co-located with, AND when remote from, product teams/leaders/managers.



+ Championing high quality SSRM deliverables, and innovation.







**Qualifications:**







+ MD (physician) or DVM (veterinarian). Others: PharmD (pharmacist); PhD; MSc; or equivalents. Appropriate Pharma experience in SS & RM.



+ DA-specific knowledge is preferred.



+ Thorough understanding of Safety Risk Management internal and external environment, including applicable regulations and guidances.



+ Displays a sound understanding of the scientific basis for therapies and drug-induced diseases. Comprehensive knowledge of drug development process.



+ Clinical development and post-marketing experience to have an understanding of safety context across the drug lifecycle.



+ Able to act independently, seeking guidance as appropriate. Demonstrates leadership in day-to- day activities and collaborative skills.



+ Can 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.



+ Recognizes other colleagues' areas of expertise and utilizes them effectively to achieve team objectives. Runs effective meetings, including all colleagues' diverse opinions and bringing group to consensus. Next steps and actions are clear.



+ 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.







Day (standard) (United Kingdom)



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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