Director Safety Risk Pharma Pfizer Collegeville

Job Description
* Safety Risk Leads (SRL) perform proactive Safety Surveillance (SS) and Risk Management (RM) for assigned products to accomplish safety signal detection & evaluation, risk assessment and safety risk minimization.
* SRLs in the Safety Surveillance and Risk Management (SSRM) line function are assigned as the product "safety-management-team" (e.g. Risk Management Committee (RMC)) chairs and are the product core team safety representatives, flexibly supporting all Business/Research Units (BU/RU). SRLs may act as a point of contact for Safety in the product teams, ensuring a unified communication on safety matters and representing Worldwide Safety and Regulatory's (WSR) positions on Safety.

Responsibilities
Colleague capability will drive Nature and Complexity of Assigned Responsibilities and Activities:
* The SRL obtains guidance from the relevant VP Safety Leads/Research Unit Leads to meet the BU/RU Safety Strategy goals.
* SRLs are assigned to act as a Safety Point of Contact to the Product Teams, ensuring a unified communication on safety matters.
* Providing and accumulating Disease Area-specific pharmacovigilance expertise, and applying this to various BUs' products assigned to the SRL operating from a SSRM DA-Cluster.
* 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 (e.g. pre-clinical, clinical, epidemiological, spontaneous, literature & regulatory alerts, 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 summary 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.
* Performing ad hoc special scholarly SS & RM activities, rapidly, to meet specific needs in the BUs, such as Rapid Response Team 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 Risk/Sciences Research & Communications activities, including methodological improvements.
* Platform for additional Centers of Excellence (e.g. Vaccines, Biosimilars, Risk Minimization, 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; Providing SS & RM support for a particular product, across the product's multiple use in different BUs
* Providing SS & RM support for a particular product in a BU, within and across the product's multiple indications in a BU
* Leveraging DA focused expertise flexibly into all BUs, and deployment to Due Diligence in-licensing assessments
* Focuses intra- and inter- DA-Cluster sharing of information between related areas (e.g. safety knowledge of Pain vs Inflammation co-prescribing)
* Enables "matrix assignment" from within SSRM to supporting VP Safety Strategy 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).

Qualifications
MD (physician) preferred. Appropriate Pharma experience in SS & RM.
* Colleague capability will drive nature and complexity of assigned responsibilities and activities.
* Some DA-specific knowledge is preferred.
* Thorough understanding of safety risk management internal and external environment, including applicable regulations and guidance.
* 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 life-cycle.
* Able to act independently, seeking guidance as appropriate. Demonstrates leadership in day-today 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.

Technical Skill Requirements:
Colleague capability will drive nature and complexity of assigned responsibilities and activities.

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
* Strong matrix partnering, inclusiveness and collaborative working relationship with colleagues, including engaging safety strategy bu lead, epidemiology leads and other colleagues supplying sources of safety information.
* 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.