The Senior Medical Director, Global Pharmacovigilance plays a key role in the safety surveillance and risk management of Life Science drug and device products, with a focus on Core Imaging injectable contrast and radiopharmaceutical diagnostic agents. Essential Responsibilities The role has primary accountability for the accuracy, adequacy and the content of periodic and ad hoc safety reports, risk management plans and safety signal detection/evaluation for assigned Life Science drug and device products, and for the oversight and management of medical and scientific staff in the aggregate reporting and risk management function. Accountable, for leading and setting strategy for proactive signal detection and evaluation, leading and managing safety committees within GPV and playing a leading role in cross-functional safety and labelling committees. Responsible for the oversight, management and effectiveness of the literature survey process. Also accountable for the successful engagement of regulatory authorities, societies and healthcare providers on safety issues.
Specific Responsibilities Include (but are not limited to):
• Oversight/coverage of medical review of SAEs and nonserious AEs occurring during clinical development and postmarketing surveillance.
• Prepares, with support from the Medical Director and/or PV Scientist, ad hoc responses to regulatory authorities
• Provides input into responses to inquiries from internal sources (such as Medical Affairs, Clinical Affairs and Regulatory), health care professionals, regulatory authorities and other external sources, as appropriate, for questions regarding safety issues of assigned products.
• Oversees and supports the development of information to be incorporated into and updates concerning safety input to the core company data sheet, core company safety information, product labelling, and the investigator's brochure for development products
• Prepares and presents relevant ICSRS and aggregate data for Safety Management Team (SMT) and Safety Review Team meetings.
• Works with the Medical Directors and PV Scientists, case processing team and others as needed, to devise appropriate safety database search strategies to proactively identify new safety issues and/or to further elucidate suspected safety issues from the medical literature that could impact on the benefit-risk profile of assigned products.
• Provides medical input to detailed reviews of events of interest including those for inclusion in Aggregate Reports (PSURs, Addendum Reports, Summary Bridging Reports, US Periodic/ Annual Reports, ASRs, DSURs, RMPs, REMS) and ad hoc analyses.
• Authors or co-authors Aggregate Reports ( PSURs, Addendum Reports, SBRs, US Periodic/Annual Reports, ASRs, DSURs) and Ad Hoc Safety Reports, and provides analytical input based on medical knowledge for known and potential risks defined in RMPs and REMS.
• Leads the development of the pharmacovigilance and risk management strategy regarding products under increased regulatory scrutiny, with accountability for the medical safety content of all documents required to implement and monitor the progress of risk management plans and for responses to ad hoc safety issues to regulatory authorities.
• Participates in review of clinical study protocol reports and other regulatory documents as necessary.
• Provides support as required for licensing activities, regulatory authority inspections, and for project product recall activities.
• Oversight and management of safety professionals within GPV within matrix teams.
• Operational oversight of the management of evolving safety issues.
• Supervision, mentoring and training of safety professionals in GPV and matrix teams on medical and GPV topics
• MD degree, or equivalent
• Minimum of 10 years of pharmaceutical/biotechnology industry experience in PV and/or clinical trials safety management/medical monitoring, with emphasis on GPV experience
• Demonstrated evidence of leadership skills in GPV
• Demonstrated evidence of management skills
• Demonstrated ability to engage, manage and deliver successful outcomes with respect to regulatory interactions and inspections, society and healthcare professional interactions, and handling of significant safety concerns
• Demonstrated experience in developing adverse event case retrieval and literature strategies for signal detection.
• Strong post-marketing and clinical trial adverse event analysis skills
• Strong aggregate data analysis and interpretive skills
• Strong working knowledge of adverse event reporting in Clinical studies.
• Strong working knowledge of US/EU/AP/LA drug safety regulations and ICH guidelines.
• Experience in communicating with the FDA, EMA, and other global health authorities, especially during GPV inspections.
• Understanding and experience supporting the QPPV
• Thorough knowledge of MedDRA coding
• Understanding of pharmacovigilance -related information systems and software tools.
• Experience in working with epidemiologists to develop and implement strategies that lead to an understanding of a product-event relationship.
• Knowledge of the pharmacovigilance and risk management strategy regarding products under increased regulatory scrutiny Additional Eligibility Qualifications GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen. Desired Characteristics • Demonstrated ability to work effectively in a collaborative, matrix environment
• High integrity, sense of urgency, ability to recognize time sensitivity, willingness to be a "player/coach" as necessary.
• Excellent written and verbal communication skills, strong listening skills and presentation skills, good negotiating and influencing skills
• Excellent knowledge of and fluency in spoken and written English. Knowledge of other languages helpful.
• Experience with diagnostic imaging agents desirable.
• Medical Device experience desirable
• Available for domestic and international travel as needed