Associate Director, Medical Safety Review

1-4 years

Not Disclosed

Hyderabad

10 June 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

Functional Area Description

The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines. The group handles 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, 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 determining regulatory reportability of clinical trial cases and certain post-marketing reports. This role supports signal detection and risk management-related activities.

Position Responsibilities

Medical Review:
- Provides high-quality medical assessment of ICSRs, particularly 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.
- Oversees single case processing vendor regarding 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 regarding 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.
- Collaborates 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 Partners (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 obtain important missing information if needed.
Development/Processes:
- Identifies safety-related issues and escalates them to MR TA Head and MSAP as needed.
- Addresses safety-related issues using critical medical and regulatory analytical strategies to develop optimal solutions.
- Acts as an active, high-energy proponent of the Company’s commitment to public health.
- Influences and impacts others through clear, reasoned argument, helps drive consensus of opinion, and catalyzes action to meet critical regulatory objectives.
- Represents WWPS within areas of responsibility, competence, and experience.
- Ensures tasks are performed efficiently while maintaining quality, accuracy, and safety, aligning 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 individual adverse events.
Previous experience in the safety field and/or pharmaceutical industry preferred.
Experience working in a team environment, supporting team members when necessary, and promoting collegiality and teamwork among peers.
Ability to think clearly and decisively and present independent, reasoned solutions to identified safety issues, drive consensus of opinion, and catalyze action to meet critical regulatory objectives.
Demonstrated creative problem-solving skills that enact change and drive continuous improvement.
Seeks to develop self and others, aligning 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.

If you come across a role that intrigues you but doesn’t perfectly align with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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. 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 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 presence. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive company culture.
Field-based and remote-by-design roles require the ability to travel to visit customers, patients, or business partners and to attend meetings on behalf of BMS as directed.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support. Applicants can request accommodations during the recruitment process. For accommodations, direct inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for our complete Equal Employment Opportunity statement.

Covid-19 Protocol

BMS cares about 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 stay updated with Covid-19 boosters.

Equal Opportunity Employment

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

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

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Associate Director, Medical Safety Review

Job Description

Job Description

Working with Us

Functional Area Description

Position Summary / Objective

Position Responsibilities

Degree Requirements

Experience Requirements

Key Competency Requirements

Uniquely Interesting Work, Life-changing Careers

On-site Protocol

Covid-19 Protocol

Equal Opportunity Employment

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