What's in it for you?
The Senior Medical Director is a drug safety physician who monitors the safety profiles and provides periodic benefit-risk assessment for assigned products during the product lifecycle. He/she is responsible for safety surveillance, risk management, and risk communication for assigned products as well as medical assessment of individual adverse event reports, generation, and review of aggregate reports and safety documents, including labeling changes.
Reporting to the Head of Pharmacovigilance, the Senior Medical Director will lead cross-functional safety management team (SMT) and collaborate with other members of the pharmacovigilance team and cross-functionally including clinical, regulatory, contract research organizations (CROs), and drug development collaborators/partners to ensure that all clinical safety and benefit-risk assessment is performed adequately for assigned products.
What will you be doing?
- Lead product safety surveillance and oversee evolving safety and benefit-risk profiles for assigned products
- Lead cross-functional safety management team (SMT) for assigned products, and responsible for the on-going assessment of benefit-risk profiles and related actions during the product life cycle
- Review safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the life cycle of assigned products
- Responsible for the conducting signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information
- Represent pharmacovigilance on cross-functional product/project teams including review of safety sections of protocols, investigator brochures, informed consent forms, marketing documents, and other documents providing safety content
- Responsible for strategy and key content of Risk Management documents (RMPs, REMS) and regulatory responses
- Provide strategy and guidance to safety scientist in writing of periodic reports for assigned products; provide medical interpretation, review and approval
- Responsible for up to date representation of safety information in Company Core Data Sheet and Investigator Brochure, and other labeling documents
- Perform the medical review of all adverse event reports for seriousness, expectedness and causality
- Collaborate with PV team members to ensure appropriate and timely communication/dissemination of safety information
- Coach, mentor and manage safety scientist(s) supporting the surveillance activities for assigned products
- Represent Pharmacovigilance function in leadership committees and activities both internally and externally when appropriate
- Represent pharmacovigilance for regulatory inspections and audits and contribute in developing corrective action plans when needed
What are we looking for?
- MD degree in a health science, with 3-5 years of relevant clinical experience
- Post-graduate trainings in epidemiology (e.g. MPH) is an added benefit but not an absolute requirement
- At least 5 years of experience in pharmaceutical industry within Drug safety/Pharmacovigilance with both investigational and marketed products
- Experience with global BLA/NDA submissions and regulatory interactions a plus
- Experience in therapeutic areas e.g. pulmonary arterial hypertension, hematology is preferred
- Expert knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidance's related to pharmacovigilance and Good Clinical Practices, as well as working knowledge of Code of Federal Regulations regarding drug safety
- Ability to achieve compliant solutions to complex problems in which analysis of situations or data requires an in-depth, strategic evaluation of various factors
- Must have excellent, concise writing skills, excellent communication and interpersonal skills, and experience in working in multidisciplinary teams
- Demonstrated leadership skills and ability to influence across external functions and within internal team