General Electric Marlborough , MA 01752
Medical Director, Drug Safety
Posted 6/12/2018 5:56:15 PM
Job Function: Engineering/Technology
Business Segment: Healthcare Life Sciences
Location(s): United States; Massachusetts; Marlborough
The Drug Safety Medical Director works within Drug Safety & Risk Management group. Individual will perform proactive Safety Surveillance and Risk Management with focus on signal detection and evaluation, risk assessment and safety risk minimization. In addition, s/he will be responsible for providing drug safety and pharmacovigilance support for clinical trials and observational post-marketing studies.
Leads safety signal detection activities. Makes data-driven decisions and writes safety review documents and reports. Determines resolution of signals. Evaluates and make recommendations on actions arising from signals in collaboration with the Safety Review Team.
Be the content owner for all safety relevant content or safety relevant documents during clinical development (e.g. DSUR, Development RMP, Safety Management Plans) and post approval (e.g. PSUR, RMPs, medical expert statements).
Responsible for development and maintenance of Company Core Safety Information (CCSI). Presentation of safety related changes and justifications to Global Labeling Committee.
Responsible for overseeing pharmacovigilance activities related to clinical trials and post-marketing safety studies. Provide input to adverse effect related sections of Study Protocols.
Leads and provides medical input to responses to safety questions from regulatory authorities. Prepare medically sound statements within agreed time frames and with a high standard of accuracy.
Prepares and contributes to written safety assessments and benefit-risk evaluations.
Serve as a back-up Medical Reviewer for Individual Case Safety Reports.
Serve as a Subject Matter Expert (SME) for Global Pharmacovigilance and cross-functional teams on relevant ICH/EU/US clinical and post-marketing safety regulations and guidelines; and product-specific information.
Other activities, special projects and assignments may be given as required. As a result, the percentage of time spent across roles for which the employee is responsible for or assisting with will vary depending on project assignments and the requirements within the department.
MD or equivalent (D.O., M.B.B.S, etc.)
3-5 years of experience in risk management and pharmacovigilance (safety signal detection, data mining techniques, preparation risk management plans, aggregate reports and company core safety information) is required or having relevant clinical development/pharma experience would be considered
Experience in the clinical and drug development process in a global pharmaceutical/biotechnology company is highly desirable
Track record of successful management of product safety matters (signal resolution, labelling, etc.) preferred
Experience with medical writing and delivering high quality documents.
Excellent communication skills.
Ability to function in an environment of rapidly changing priorities and to manage multiple projects simultaneously while maintaining a high level of quality, accuracy and attention to detail.
Ability to act independently and to take initiative as well as work within a team. Self-starter, able to work with a high degree of independence.
There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more
than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60
years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping
accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with
cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present
and the future. We are accelerating biology to cell therapy in ways no other company can.
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GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Locations: United States; Massachusetts; Marlborough
GE will only employ those who are legally authorized to work in the United States for this opening.