WSS SSRM Safety Risk Lead Job in New York, New York US
WSS SSRM Safety Risk Lead
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 Safety Risk Leads (SRL) in Safety Surveillance and Risk Management (SSRM) will be the Chairs of the product Risk Management Committee and other safety management teams and the safety representatives on the Product Teams, flexibly supporting all Business Units (BU). SRLs perform proactive Safety Surveillance (SS) and Risk Management (RM) including product safety signal detection evaluation, risk assessment and safety risk minimization. Responsibilities § Providing and accumulating DA-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 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 activities). § Engagement in inspection readiness and support. § Provision of data to project managers for metrics and activity tracking. Qualifications § M.D. required § In depth and broad understanding of safety signal management. Certain DA-specific knowledge can be preferable (for example Cardiovascular/Metabolic/Endocrine, Neurosciences/Pain and Consumer/Nutrition). § 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. 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 WWS/WSRO colleagues, including engaging Safety Strategy BU Lead, Epidemiology Leads and other colleagues supplying sources of safety information. Actively engages WSRO WSS colleagues in RMCs and Asset teams as needed. ~ Effectively communicating resource, timeline and other issues that have e.g. regulatory impact, to the Safety Strategy BU Lead(s). ~ 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. Equal Employment Opportunity 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 employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Pfizer in the U.S. In certain circumstances it may be advantageous to Pfizer to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Pfizer and the specific job and/or work site. Pfizer may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Pfizer in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Pfizer's support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Pfizer. Click Here To Apply Now