Director -Safety Risk Lead (MD) Job in Collegeville, Pennsylvania US
Director -Safety Risk Lead (MD)
Org Marketing Statement Pfizer Inc: Working together for a healthier world Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide. Role Description - SRLs perform proactive Safety Surveillance (SS) and Risk Management (RM) to effect product safety signal detection evaluation, risk assessment and safety risk minimization. - 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.SRLs may act as a Point of Contact for Safety in the Asset Teams, ensuring a unified communication on safety matters and representing WSS position(s) on safety. 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 below 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 WSS VP Safety Strategy Business Unit/Research Unit Leads to support the appropriate BU safety strategies. o The SRL obtains guidance from the relevant WSS VP Safety Strategy Business Unit/Research Unit Leads to meet the BU/RU Safety Strategy goals. o SRLs may be assigned to act as a Safety Point of Contact to the Asset Teams, ensuring a unified communication on safety matters for WSS/WSRO. " 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 WSS/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 WSRO 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 BUs o Providing SS RM support for a particular product in a BU, within and across the product's multiple indications in a BU o Leveraging DA focused expertise flexibly into all BUs, and deployment to Due Diligence in-licensing assessments o 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 Safety Strategy BU Leads 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). Director -Safety Risk Lead Capabilities and Continuum PV/RM analytical activities -Strong understanding of clinical and epidemiological trial design methods, protocols and statistics as applicable to safety assessments -Fundamental cross-drug lifecycle PV RM competency. -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. -Solid understanding of global PV regulations and guidances with a focus on signal management with risk management (detection/evaluation/ADR and risk identification, Risk and B-R assessment and management) -Actively contributes safety strategy perspective on cross-functional project teams. May provide DA-specific expertise on more complex issues or contribute to strategic governance bodies such as Technical Review Committees (TRC), Disease Area Strategy Teams (DAST), and Product B-R Committees (PBRC). -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. Leadership -Usually functions as the primary SRL responsible or accountable in SSRM for assigned products and product teams. -Partners with Associate-SRL for care of assigned products. -Chairs RMC, may chair SR-CWGs, co-chairs PBRCs, and relevant subcommittees e.g. RMP/REMS CWGs. Demonstrates sound judgment in escalating safety issues through governance process or seeking management input on complex issues as necessary. -Proactive and takes initiative. -May provide guidance and/or oversight to SSRM colleagues on safety issues. Can provide formal and informal education to other SSRM colleagues on key safety and pharmacovigilance topics. -Provides subject matter and safety expertise, actively builds consensus with colleagues in other departments, and facilitates issue resolution regarding safety and benefit-risk issues. May represent SSRM to business partners. -Learns to represent WSS on safety and benefit-risk issues to external groups including regulatory authorities and business partners. -Reviews and approves safety and B-R documents, and may be delegated to do so for DAHs. -May contribute to review and development of intradepartmental policies and procedures. -Independently makes decisions on assigned products with ad hoc oversight. Communication -Initiates, conducts and chairs RMC, P-BRC (co-chair) and CWGs with minimal oversight. -Prepares and contributes to written safety assessments and benefit-risk evaluations. -Writes and presents medical opinion in a professi