Senior Manager, PV System Excellence And Intelligence

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.

BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.

Position Summary

• Support quarterly and ad hoc maintenance of key elements of the global BMS Pharmacovigilance System Master File (PSMF).
• Oversee the creation and the maintenance of local market PSMFs as required.
• Support the management of PSMF related projects focusing on data integrity and process enhancement
• Manage safety actions screening process of Health Authority website for Countries where BMS is acting as Marketing Authorization Holder
• Support Pharmacovigilance intelligence related activities
• Support Safety Aggregate reports Health Authorities submission activities (i.e. submission package documentation, late submission Verity tracking etc) as applicable

Position Responsibilities

• Manage quarterly and ad hoc update of sections/annexes -as assigned- of the global BMS PSMF by initiating workflows notification and overseeing the workflows execution and completion in the electronic PSMF management system
• Support the creation and maintenance of local market PSMFs as required via the electronic PSMF management system
• Support the management of PSMF related projects focusing on data integrity and continuous process enhancement
• Prepare submission package documentation for Centrally Authorized Products (CAP) and non-CAP products Safety Aggregate reports in the EEA and manage related documentation activities as applicable (i.e. Verity tracking of late submission(s) as applicable)
• Support users’ first access and ongoing users’ access rights maintenance into the electronic PSMF management system (i.e. sharing settings)
• Support updates to the QPPV Office share point site for PSMF content as required.
• Support PSMF Content Responsible Persons as required
• Screen Health Authorities websites for notices of Safety Actions pertaining to BMS authorised products (active substances) for US, the EEA and applicable countries, document the screening and escalate any identified safety actions as per existing BMS process
• Support Pharmacovigilance intelligence activities -as required- according to existing BMS processes
• Maintain the PV intelligence repository as required

Degree Requirements
Required degrees, certifications, and/or licensure relevant to role.

University degree (preferably health or life science) or nursing qualification

Experience Requirements
Minimum number of years of relevant experience expected.

At least 5 years in the Pharmaceutical Industry, usually with at least 3-5 years’ experience of working in Pharmacovigilance or in a closely aligned field (e.g. Regulatory, Clinical, or Medical Information) within the pharmaceutical industry, medical or Regulatory environment.

Key Competency Requirements

• Strong, effective organizational, facilitation, interpersonal and communicating skills with cross-functional stakeholders.
• Communicate with clarity and consistency to achieve alignment of stakeholders’ activities.
• Utilizes effective problem-solving approach to address issues, in a timely manner. Has a clear understanding of the broader impact and possible implications on processes/the environment and appropriately consults or escalates (via designated channels) clearly articulated issues
• Ability to manage multiple tasks and utilize effective problem-solving approaches and follows up and resolves outstanding issues.
• Solves complex problems by reviewing data flows and leveraging digital tools and methods.
• Experienced in advanced functionalities of operational tools. Integrates/utilises digital automations tools into daily workflows.
• Ability to optimize existing processes through incremental improvements and digital enhancements to help pre and post process teams.
• Microsoft Suite
• Other systems as needed

#HYDDD #LI-Hybrid

If you come across a role that intrigues you but doesn’t 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 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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