Associate Director, Medical Safety Review

3 days ago

Hyderabad, India Bristol Myers Squibb Full time

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.

Position Summary / Objective

The Associate Director, Medical Safety Review provides high quality medical review of Individual Case Safety Reports (ICSRs) including the determination of regulatory reportability of clinical trial cases and certain post-marketing reports. Supports signal detection and risk management-related activities.

Position Responsibilities

Medical Review : Provides high quality medical assessment of ICSRs with particular attention to critical cases (SUSARs, AEs of Interest, potential Drug-Induced Liver Injury [pDILI], pregnancy, any critical events). Provides seriousness, causality and expectedness assessment and determines regulatory reportability of ICSRs for assigned products. Provides oversight of single case processing vendor re: medical review for products of responsibility if applicable. Leads Case Processing & Review meetings for assigned products. Supports signal detection and risk management requirements globally for assigned products throughout the product life cycle. Executes RMP re: ICSR/medical review-related Pharmacovigilance (PV) activities. Ensures special health authority requirements are met pertaining to medical assessment and submission of ICSRs. Compliance : Ensures complete and timely reporting of ICSRs to regulatory authorities globally for products of responsibility. Implements quality and compliance controls pertaining to medical review of ICSRs. Collaborate with Quality, Standards and Training teams to ensure consistency of work practices and SOPs. Applies BMS operating philosophy and operates within company policies and procedures and appropriate regulations. Collaboration : Partners with WWPS personnel from other functions (Case Management, PV Scientists, Expedited Safety Reporting [ESR] Safety Scientists, and Medical Safety Assessment Physicians [MSAP]), Clinical Development and Business Partner (if applicable) in evaluating the safety profile of BMS compounds of responsibility. Ad hoc member of Safety Monitoring Team (SMT). Identifies potential safety signals and informs the MSAP of all potentially important cases and issues. Escalates critical cases to the Clinical Development lead for the compounds of responsibility and proposes action to get important missing information if needed. Development/Processes : Identifies safety-related issues and escalates them to MR TA Head and MSAP as needed. Deals with safety-related issues using critical medical and regulatory analytical strategies to develop optimal solutions. Is an active, high-energy proponent of the Company’s commitment to public health. Influences and impacts others through clear reasoned argument, helps to drive consensus of opinion, and catalyzes action to meet critical regulatory objectives. Represents WWPS within areas of responsibility and competence and experience. Ensures that the above tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and safety in accordance with Company cost effectiveness goals.

Degree Requirements

Education Required : MD or Equivalent. Board certification and medical specialty 

preferred.

Experience Requirements

Minimum 2-4 years in clinical practice or relevant setting. Minimum 1-3 years of pharmaceutical industry experience.

Key Competency Requirements

Knowledgeable and skilled in medicine and pharmaceutical product safety. Experience applying medical knowledge to the interpretation of individual case review; experience with reporting of individual adverse events. Previous experience in the safety field and/or pharmaceutical industry preferred. Experience working in a team environment, including supporting other team members when necessary; promoting collegiality and teamwork among peers. Ability to think clearly and decisively and present independent, reasoned solutions to identified safety issues, helps to drive consensus of opinion, and catalyzes action to meet critical regulatory objectives. Demonstrated creative problem-solving skills that enact change and drive continuous improvement. Seeks to develop self and others. Align objectives with organizational goals. Excellent oral and written English skills.  Excellent communication, interpersonal and time management skills. Demonstrated flexibility, open-mindedness and adaptability in a rapidly changing environment. Ability to build and manage interrelationships by motivating and inspiring others.  Ability to operate autonomously. Experience in Aris-g safety database is preferred. 

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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