Job Description

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: .Functional Area Description

• The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines. This includes all 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

• Provide administrative leadership and management of the PV Operations & Systems Group in Hyderabad.
• Support and deputize for the WWPS Site Lead Hyderabad in administrative leadership responsibilities.
• Provide vendor oversight and monitoring with regard to ICSR medical review quality.
• Ensure continuous compliance and quality excellence with all applicable processes, safety guidelines and regulations to mitigate potential risks associated with PV activities delivered by WWPS.
• Lead training and quality monitoring activities (content and delivery) for BMS Medical Review group in Hyderabad.
• Contribute to MR continuous improvement (identify, present, implement).

Position Responsibilities

• Functions as the PV Operations Administrative Site Lead for up to 40 staff in PVOpS Hyderabad including Medical Review, Case Management and Systems teams. Deals with HR and general work-related matters that require local administrative leadership.
• Reports into WWPS Lead Hyderabad and functions as their deputy in administrative leadership matters such as WWPS representation on the BMS Hyderabad R&D Leadership Team.
• Leads and performs Quality Monitoring of ICSRs that were processed by the vendor for medical accuracy.
• Oversees random sample line listing of serious cases approved on the previous business day that have been selected and reviewed by Pharmacovigilance (PV) Compliance and Vendor quality monitor to assess the accuracy and completeness of the fields for the ICSRs in the safety database pertinent to medical review as per ICSR Processing Work Instruction.
• Discusses findings with Head of Medical Safety Review Quality Monitoring as needed and participates in weekly Medical Review meetings.
• Communicates case quality results to Case Management representative(s) as needed.
• Provides feedback on errors to the relevant MR/MR team; identifies knowledge gaps and conducts training/knowledge sharing sessions as needed.
• Contacts Case Management and PV Compliance and Vendor quality monitor to initiate necessary corrections as needed.

• Works closely with PV compliance and Vendor Quality Monitor records the assessment results on the appropriate score cards per the Worldwide Patient Safety (WWPS) Quality Systems Manual.
• Reviews daily non-serious line listing report generated from the corporate safety database for accuracy of case seriousness assessment and initiates necessary corrections and related communication.
• Documents, tracks, and analyzes quality trends and results through a monthly quality forum.
• Ensures effective communication with key WWPS stakeholders and vendors (where applicable) to include review of their performance metrics ensuring the expectations are met and that delegated functions are performed in accordance with contractual and regulatory requirements.
• Provides support to Head of Medical Safety Review Quality Monitoring in developing and maintaining training materials related to medical assessment of ICSRs.
• Supports the training of new MRs upon onboarding and ensures appropriate training delivered as per WWPS standards.
• Supports Head of Medical Safety Review Quality Monitoring in collaborating with PV Compliance and Quality team to ensure consistency of work practices and SOPs. Collaborates with MR TA Heads to ensure MRSPs meet or exceed expectations for compliance, quality, regulatory and safety initiatives.
• Applies BMS operating philosophy and operates within company policies and procedures and appropriate regulations.

Degree RequirementsEducation required: MBBS / MD or Equivalent. Board certification preferred.Experience Requirements

• Previous people leadership responsibility
• Minimum of 2 years in medical clinical practice or relevant setting.
• Minimum 5 years of corporate pharmaceutical industry experience of which at least 3 years was dedicated to the medical evaluation and reporting of individual adverse events.
• Quality monitoring experience preferred.
• Experience with global safety databases is required, ArisG safety database experience is preferred.

Key Competency Requirements

• Differential diagnosis skills - application of medical knowledge to the interpretation of individual adverse event reports
• Excellent medical writing
• Sound knowledge of reporting requirements for individual case safety reports.
• Knowledge and skills in medicine and pharmaceutical product safety, ICH Guidelines and relevant US and EU PV regulations. Able to interpret regulations and create new processes as needed.
• Good knowledge of MedDRA and WHO Drug Dictionary use.
• 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, ability to drive consensus, and to catalyze action to meet critical regulatory objectives.
• Demonstrated problem solving skills that enact change and drive continuous improvement.
• Self-and people developer. Align objectives with organizational goals.
• Excellent oral and written English skills.
• Excellent communication, presentation, 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.

If you come across a role that intrigues you but doesnt perfectly line up 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, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS 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.

Bristol-Myers Squibb