Location(s): United States ; Massachusetts; Marlborough
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Role Summary: The Medical Director, Global Pharmacovigilance plays a key role in the safety surveillance and risk management of GE Healthcare Life Science drug and medical device products, with a focus on Core Imaging injectable contrast and radiopharmaceutical diagnostic agents and medical devices. Belongs to the Global Safety Risk Management group within GPV. Reports to Sr Medical Director Global Pharmacovigilance, and QPPV.
Essential Responsibilities: This position has primary accountability for the accuracy, adequacy and the content of aggregate reports and ad hoc safety reports, risk management plans and safety signal detection/evaluation for assigned Core Imaging drug and medical device products. May include the oversight and management of medical and scientific staff in the Safety Risk Management group.
Also, this role has accountability for leading and setting strategy for signal detection and evaluation, preparing in and contributing to safety committees within GPV and playing a leading role for relevant products in cross-functional safety and labelling committees.
Responsibility also includes the timely conduct and the effectiveness of the literature survey process; in collaboration with the Senior Medical Director, or the successful engagement of regulatory authorities, societies and healthcare providers on safety issues; and for supporting cross-functional internal teams as needed on safety matters.
Specific Responsibilities Include (but are not limited to):
Conducts timely medical review of SAE reports and nonserious AE reports occurring during clinical development and postmarketing surveillance.
Collaborates with and supports the PV Case processing team
Prepares, with support from the Medical Director and/or PV Scientist, periodic and 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.
Assists in 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 PV Scientist, case processing team and others as needed, to devise appropriate safety database search strategies to proactively identify new safety issues 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, US Periodic/ Annual Reports, ASRs, DSURs, RMPs, REMS) and ad hoc analyses.
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.
Supports the development of the pharmacovigilance and risk management strategy regarding products under increased regulatory scrutiny, with responsibility 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.
Responsible for management of evolving safety issues for assigned products.
Supports the education, mentoring and training of safety professionals in GPV and matrix teams on medical and GPV topics
MD degree, or equivalent
Minimum of 3 years of pharmaceutical/biotechnology industry experience in PV and/or clinical trials safety management/medical monitoring, with emphasis on GPV
Experience and ability to engage, manage and deliver successful outcomes with respect to regulatory interactions and inspections, and handling of significant safety concerns
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
Working 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
Quality Specific Goals:
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
Complete all planned Quality & Compliance training within the defined deadlines
Identify and report any quality or compliance concerns and take immediate corrective action as required
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
Locations: United States ; Massachusetts; Marlborough
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