工作职责: DC Safety Liaison director role: Manage all CRDC cross functional activities related to safety as assigned, develop DC RMP strategy annually Act as a Point of Contact for Safety in the DC, ensuring a unified communication on safety matters and representing DC position(s) on safety risk management plan. Work as Development China (DC) representative to be part of the RMP development and implementation team Plan RMP development, revision, translation, validation and tracking. Define the RMP China contributors to each required section/question which are requested by Global RMP owner or RMP author. Organize RMP China contributors to participate the RMP review meeting via RMC (risk management committee) or the product risk management strategy (PRMS) sub-team. Lead RMP development team assess HA correspondence. Organize RMP implementation kick off meeting to work out implementation plan of non-routine RMP activities. Submission of Periodic Study Report.
Engages in inspection readiness and support, and due diligence activities. Contributes to review and development of local WI, intradepartmental policies and procedures as appropriate. Initiates, conducts and chairs Risk Management Plan Committee with appropriate oversight. Review and contributes to written safety assessments and benefit-risk evaluations. Reviews and tracking safety assessments/evaluations/contributions prepared by senior manager SRLs and other safety colleagues. Completes all assigned activities with minimal guidance.
MD Makes decisions based on clinical experience. Utilizes knowledge of integrated body systems’ pathophysiology to evaluate the impact of product issues. Assesses the suitability of biopharmaceutical products on typical physician practice within various health systems, hospital and non-hospital patient care facilities. Ensures products fulfil quality medical care. Innovative technology related to safety in development Responsible to lead Dev China, in line with the DC and global strategy, to:
Support to develop Volume 3 China strategy. Leads teams that set strategic direction. Influences senior management decisions that have an impact on business direction, especially in the safety related objectives Improve the efficiency of our work by adopting innovations in clinical research, especially in the post marketing studies (PMS) , RWE, PAC with safety purpose. Anticipates, oversees and influences change that has a transformational impact in safety related area
Support and Cooperate with other colleagues within CRDC Strategy and Technology Innovation
Support Head of DC Strategy and Technology Innovation on decision making by collecting and summarizing product safety information; contribute to safety strategies for DC and lead matrix team projects or meetings as required. Drive and implement Innovation program in safety strategy Input for the overall external KOL management, especially on those related to safety
Technical Skill Requirements Technical 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.
任职资格: Qualifications (i.e., preferred education, experience, attributes) Education: MD (physician) degree required (for MD role) Education: DVM (veterinarian), PharmD (pharmacist), PhD degree Minimum 10 years of: medical (e.g. patient care, clinical trial experience/investigator, academic medicine, specialty training and/or board certification), and/ or scientific, and/or pharmacovigilance or and/or drug development experience required Education: MSc degree (Health Care Related) (for non-MD role) Minimum 10 years of: medical (e.g. patient care, clinical trial experience/investigator, academic medicine, specialty training and/or board certification), and/ or scientific, and/or pharmacovigilance or and/or drug development experience required Disease Area specific knowledge is preferred. Thorough understanding of Safety Risk Management internal and external environment, including applicable regulations and guidance. Clinical development and post-marketing experience to have an understanding of safety context across the drug lifecycle Demonstrated leadership in day-to-day activities and collaborative skills Demonstrated self-awareness and interpersonal skills Appropriate external stakeholder engagement skill and professional compliance sense
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