Organizational Change Management Consultant driving IT outcomes and guiding clients in digital transformations at Kyndryl. Leading OCM activities on high - complexity changes with strong client interactions.
About the role
- Director of Medical Safety Assessment leading safety activities and benefit-risk strategies for BMS compounds. Overseeing clinical documents and safety evaluations in compliance with regulatory standards.
Responsibilities
- Lead safety activities and benefit-risk strategies for assigned BMS compounds/ program and chair the product Safety Management Team(s).
- Oversee, prepare and/or review aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings.
- Lead team in the evaluation & management of safety signals emerging from any data source. Develop strategy for signal evaluation and document outcome.
- 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.
- Lead process improvement projects. Assist the MSA Therapeutic Area (TA) Head/Lead in developing and maintaining state-of-the-art PV processes and procedures within BMS R&D and PS.
- Provide input to R&D publication strategy/ plan & ensure safety input to publications/ presentations.
- Actively drive safety strategy preparation and Represent PS at Health Authority (HA) and Data Monitoring Committee (DMC) meetings.
Requirements
- MD/equivalent required.
- Postgraduate qualification or experience in psychiatry or neurology preferred.
- 3+ years in PV or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) is strongly preferred.
- Understanding of the drug development process.
- Knowledge of PV and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product.
- Proficient ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.
- Understanding of regulatory requirements for safety assessment and action.
- Strong scientific analytical reasoning skills.
- Ability to work on multiple projects in parallel.
- Excellent attention to detail.
- Excellent verbal and written communication skills.
Benefits
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
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