Bristol Myers Squibb - Manager - International Patient Safety

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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.

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

Position Summary :

The International Patient Safety (IPS) team ensures robust, compliant, and consistent safety and risk management across all territories in which BMS operates, including Distributor and Local Representative (LR) markets.

This role is responsible for executing various pharmacovigilance (PV) activities in accordance with local regulatory and legal requirements, as well as BMS procedures, under the direction of the IPS Leader (or Oversee, mentor and guide Senior Specialists in IPS, to ensure high-quality safety deliverables across the team.

• Contribute to / Lead the creation and maintenance of risk management plans & provides support for the effective implementation of Additional Risk Minimisation measures.
• Safety mailbox and communications management.
• Support / Lead Aggregate Report related activities.
• Lead the creation / update of PV Awareness and other related Training content.
• Implementation of Pharmacovigilance Agreements.
• Individual Case Safety Report (ICSR) related activities, including literature screening, and submissions to local Health Authorities and Ethics Committees.
• Safety Data Quality activities e.g PV System Master File maintenance, deviations / CAPA management, other quality control and oversight activities.
• Compilation of PV-related documentation for third parties responsible for Distributor / Local Representative Markets.
• Lead the oversight of the performance of Distributor / Local Representative Market third parties, in line with PV Agreement key performance indicators.
• PV activity planning and tracking e.g signal communications to Health Authorities.
• Collaborate and support cross-functional teams to ensure effective conduct of PV activities.
• PV Audit and Inspection support (including preparation, conduct and follow-up actions.
• The responsibilities listed above are only a summary, and other responsibilities will be determined by the IPS Leader, as required.

Reporting Relationship :

Functional and Managerial reporting lines into IPS.

Qualifications / Experience :

Analytical Skills :

Strategic Skills :

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 a supportive culture, promoting global participation 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 BMS has an occupancy structure that determines where an employee is required to conduct their work.

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.

(ref : iimjobs.com)