Description

• Work closely with cross-functional team members including those from clinical development, epidemiology, regulatory affairs, statistics, and manufacturing to manage safety topics under evaluation to ensure efforts are aligned to meet global pharmacovigilance and risk management strategies for assigned products.
• Support or Chair the cross disciplinary Safety Review Team for leading benefit risk topics
• Accountable for scientific strategy for safety related documents (e.g., CTD components, Risk Management Plans (RMP) and Periodic Safety Update Reports) and for ensuring that the safety sections of Company product circulars are medically and scientifically appropriate.
• Responsible for safety surveillance activities such as aggregate clinical trial data analysis and post approval safety signaling reviews, using medical judgement in review of aggregate data and individual cases.
• Responsible for the development of RMPs, pharmacovigilance strategies and risk minimization activities as warranted.
• Prepares safety summaries and analyses of safety related data for regulatory documents and aggregate reports and may supervise the activities of Staff in the execution of safety data analysis and authoring of regulatory documents.
• Contributes to or leads and driving safety strategy for the development of assigned products.
• Contributes to or lead all interactions regarding product safety issues with Research & Development governance committees and regulatory agencies.
• Work closely with Leadership to implement the evolving direction for the risk management and safety function of the department, as well as helping to develop and align processes to support departmental objectives.
• Contribute to or lead safety labeling activities for assigned products/ program. Act as the Safety Subject Matter Expert for input to regulatory product labeling. Participate/ Provide input at cross-functional labeling team meetings and provide regional safety labeling support.
• Provide safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plan (SAP), ICF, CSR, responses to HA or institutional review board (IRB)/ ethics committee (EC) queries.
• Contribute to or lead development of safety risk language, risk management strategy, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, safety-focused publication development.
• Perform medical safety review of DSUR, annual reports, and other periodic safety submissions.
• Represent DSPV at HA meetings. Actively drive safety strategy preparation for pre-submission meetings, Advisory Committee meetings, Scientific Advice meetings, DMC meetings, etc.
• Identify data gaps and Prioritize data acquisition. Provide input to strategic plans for safety differentiation of products.
• Act as liaison for assigned products with internal functions (Legal, BD, Operations, Marketing, etc.).
• Support manufacturing quality. Co-Author integrated health hazard assessments.
• Develop communications of safety data & interpretation to internal and external parties, globally.
• Contribute to the further development of pharmacovigilance by staying informed and addressing changes in the regulatory environment and developments and trends in the discipline.
• Contribute to or lead strategic projects within PV
• Provide updates of the assigned drug’s safety profile to senior management and recommend pharmacovigilance / risk management activities

• Required: MD, DO, or equivalent
• Preferred: Board Certification
• Minimum 3 years clinical practice experience following post-graduate medical training
• Knowledge of clinical development process
• Knowledge of other related disciplines, e.g., statistics, epidemiology relevant to assessing drug utilization and safety at the population level
• Demonstrated a desire to develop organizational leadership skills
• Excellent communication, writing and analytic skills.
• Sound medical-scientific and clinical knowledge and judgement