Manager - Operations, Medical Safety Review and Expedited Safety Reporting
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Functional Area Description
The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.
Responsibilities include planning and management of projects and operational activities within Medical Safety Review (MSR) and Expedited Safety Reporting (ESR) team. Identifies resources and plan project timelines and actions. Meeting coordination across groups and external partners. Performs other activities as assigned to support the MSR/ESR team. Manages and maintains MSR/ESR SharePoint sites and other project tools in use. Manages generation of reports from Safety Database. Coordinates the preparation of SUSAR line listing reports and oversees vendor operations; maintains related process in procedural documents. Provides administrative support to the MR & ESR team. Exhibits excellent judgment in handling confidential information. Has excellent organizational, prioritization, communication, project management skills.
Manages operational activities in the MR & ESR Team
Responsible for planning, scheduling, overseeing projects within MSR/ESR team.
Works effectively as a member of a team capable of prioritizing multiple tasks to meet project deadlines. Ensure contributors are maintaining compliance with project schedules.
Manages and facilitates generation of line listings of expedited safety reports and other adhoc SUSAR listings as required.
Plan and manage the schedule of periodic SUSAR line listings as needed based on regulatory requirements and BMS internal BMS SOPs and work instructions.
Performs assigned activities in the global safety database. Participates in the review of SAE management plans and other documents with CROs and vendors.
Oversees vendor operations pertaining to SUSAR line listing generation and submission.
Administrative responsibilities include preparation of team meeting agendas and minutes, preparation of presentations, handling of correspondences, making travel arrangements, preparing expense reports and ordering supplies. Supports onboarding new hires.
Works collaboratively with Medical Review Safety Physicians and ESR support team to complete assigned activities and projects.
Maintains organizational chart for MR & ESR.
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
Degree / Experience Requirements
Bachelor’s Degree in a relevant major (e.g. health sciences or business) preferred.
2-3 years of industry or relevant project management/administrative experience preferred.
Key Competency Requirements
Excellent verbal and written communication skills. Ability to develop and apply unique ideas, methods, processes and procedures to achieve higher performance and productivity for self and team.
Excellent problem solving skills and demonstrates diplomacy in dealing with difficult issues
Good organization skills, project management skills; ability to create charters, meeting minutes, lead projects and meetings from operational perspective.
Skilled in general administrative tasks to support team.
Demonstrate advanced level of competency in computer applications as required i.e., Microsoft Word, Excel, Power Point, SharePoint and Outlook.
Competent at invoice handling, travel planning, contracts; communicating with external partners as needed.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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