WSS SSRM Safety Risk Lead

pstrongOrg Marketing Statement /strongbr /Pfizer Inc: Working together for a healthier worldbr /br /Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture & deliver quality, safe & effective prescription medicines to treat & help prevent disease for both people & animals. We also partner with healthcare providers, governments & local communities around the world to exp& access to our medicines & to provide better quality health care & health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier & healthier longer & to reduce the human & economic burden of disease worldwide. br /br /strongRole Description /strongbr /Safety Risk Leads (SRL) in Safety Surveillance & Risk Management (SSRM) will be the Chairs of the product Risk Management Committee & other safety management teams & the safety representatives on the Product Teams, flexibly supporting all Business Units (BU). SRLs perform proactive Safety Surveillance (SS) & Risk Management (RM) including product safety signal detection evaluation, risk assessment & safety risk minimization. br /br /strongResponsibilities /strongbr /? Providing & accumulating DA-specific pharmacovigilance expertise, & applying this to various BUs' products assigned to the SRL operating from a SSRM DA-Cluster. br /? Performing frequent proactive holistic safety review for products, across the span of relevant available safety data information. Reviews are incremental, cumulative & aggregate, to include the body of safety information available from WSS/WSRO & elsewhere (e.g. clinical, epidemiology, spontaneous, literature regulatory cases, other scientific data)br /? Ensuring consistency of safety risk messaging for a particular product or class of products, across multiple indications/BUs within the many safety reports & communications for that product. br /? Providing suitable summaries of product risks to summary document authors where appropriate, for example providing medical content/B-R statements & overall risk messaging of the safety profile to WSRO Authors.br /? 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.br /? Identifying opportunities for Consistency & St&ards for SS RM approaches & processes within a DA-Cluster & across BUs, & supporting the piloting & implementation of such.br /? Innovating, championing & implementing novel approaches to SS RM across BUs: engagement in Continuous Improvement initiatives, Safety Sciences Research Communications activities, including methodological improvements.br /? Platform for additional Centers of Excellence (e.g. Vaccines, Safety Advisory Councils, Contributions to or coordination of Other Pan-BU activities).]br /? Engagement in inspection readiness & support. br /? Provision of data to project managers for metrics & activity tracking.br /br /br /strongQualifications /strongbr /? M.D. requiredbr /? In depth & broad underst&ing of safety signal management. Certain DA-specific knowledge can be preferable (for example Cardiovascular/Metabolic/Endocrine, Neurosciences/Pain & Consumer/Nutrition).br /? Thorough underst&ing of Safety Risk Management internal & external environment, including applicable regulations & guidances. br /? Displays a sound underst&ing of the scientific basis for therapies & drug-induced diseases. Comprehensive knowledge of drug development process. br /? Clinical development & post-marketing experience to have an underst&ing of safety context across the drug lifecycle.br /? Able to act independently, seeking guidance as appropriate. Demonstrates leadership in day-to-day activities & collaborative skills. br /? Can h&le more than one complex project simultaneously, prioritizing well & recognizing key issues