Senior Specialist, Patient Safety

**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.

Is responsible for performing some or all of the required core pharmacovigilance (PV) activities listed below in line with local regulatory and relevant legal requirements and BMS procedures, under the supervision of the LMPS Lead (or designee).

Risk management plans

Provision of safety information

Implementation of PV Audit and Inspection Readiness

Planning, processing and reporting of Aggregate Reports to HA and EC (as required)

Maintenance of PV Awareness and Training

Implementation of Pharmacovigilance Agreements

As applicable, collection, follow-up and forwarding of spontaneous, literature, solicited, post
- marketing AE cases
- Submission of single cases to local Health Agencies(HA) and Ethics Committees (as required)
- Local Market Safety Data Quality
- Note: for greater detail of the specific responsibilities and duties refer to the International Pharmacovigilance Core Activities of the Local Market PV Personnel. (Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Key Competency Requirements

Ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team locally, within GPVE and externally.
- Develops a good understanding of the BMS organization, in particular the Global and Regional Safety groups.

Has a good understanding of relevant local departments e.g. Regulatory and Clinical Teams and how these teams interact (or similar experience in another company).
- Possess excellent interpersonal, verbal, and written communication skills.

Able to research, compile and provide safety information in a clear concise manner to the local /regional team and GPVE HQ as appropriate.
- An understanding of local, regional and any other relevant legislation with regard to PV (e.g. ICH, CIOMS), as well as BMS corporate and local systems (e.g. Global Safety Database, local data bases) and procedures, in order to fulfill regulatory requirements for Pharmacovigilance.
- Maintains an awareness of the safety profile and any emerging PV issues with BMS products (marketed or investigational )in the local affiliate and with support able to represent the local PV function on cross functional teams, providing input on drug safety issues.
- Demonstrated ability to review safety information with attention to detail and accuracy, while managing multiple tasks & prioritizing work in order to meet strict deadlines. Utilizes effective problem-solving approaches to solve PV issues, seeking support from supervisor when necessary.

Ability to comply with relevant internal and external processes/guidelines/regulations.

**Uniquely Interesting Work, Life-changing Careers**

**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 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.