Associate, Pharmacovigilance

5 months ago

Hyderabad Telangana, India Bristol-Myers Squibb Full time

**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.

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**

The Pharmacovigilance (PV) Associate I will support administrative and operational activities for Signal Detection (SD), Safety Data Review (SDR) and Scheduled Aggregate Reports (SARs), Safety Management Team (SMT) system set-up, access support, data coordination, and tracking of actions.

**Position Responsibilities**

**Signal Detection/Safety Data Review**

**Signal Detection Support**
- Generate and file standard signal detection reports
- Execute literature searches and retrieve and delver full-text articles, as applicable
- File additional signal detection data for routine safety data review
- Schedule routine Safety Data Review Meetings (SDRMs)

**Signal Documentation**
- Generates the LEAD report and upload into Signal Tracker
- Provide Pharmacovigilance Agreement (PVA) as needed

**Safety Management Team**
- Create and manage SMT Membership List
- Create and manage SMT Mail Group
- Create and manage SMT File Share (i.e., Safety Data Review Folder)
- Create and manage associate systems (i.e., Sharepoint [SP] site, OneSafe)
- Schedule routine meetings
- Manage asset close out
- Manage MSAPSMT mailbox/meeting calendar
- Manage access, permissions and content related to SMT OneSafe and SharePoint Online for assigned assets.

**Scheduled Aggregate Report**
- Generate and file supporting data
- Support literature searches and deliver full-text articles

**Other Activities**
- Manage data received in PV mailbox.
- Close safety-related health authority queries in Verity.
- Support data tracking, reporting, and querying follow up

**Degree Requirements**

BS/RN/MS/PharmD in life sciences or equivalent relevant scientific qualifications or professional training.

**Experience Requirements**

**Must have requirements**:

- Bachelor of Science in life sciences or equivalent relevant scientific qualifications or professional training.
- Minimum of 2 years professional experience in health science or relevant life sciences/medical fields, or appropriate pharmaceutical industry or academic experience
- Demonstrated understanding of global pharmaceutical drug development and lifecycles.
- Demonstrated excellence in scientific technical skills with a comprehensive understanding of pharmacovigilance processes.
- Extensive experience in the organization, coordination, and communication of data and information.
- Project or program management experience and/or qualifications.
- Experience in working with diverse teams.

**Key Competency Requirements**
- Working understanding of pharmacovigilance activities/processes and medical concepts.
- Working understanding of team priorities and milestones.
- Ability to manage timelines and quality of work using organizational and interpersonal communication skills.
- Good collaborative and communication skills.
- Attention to detail with scientific, analytical and conceptual skills and the ability to reach reasoned conclusions.
- Possess good working skills in MicroSoft Office (or equivalent) programs (e.g., Word, Excel, PowerPoint, SharePoint Online, Outlook)
- Understanding of scientific data

HYDDD #LI-Hybrid

**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 directe

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