Associate, Pharmacovigilance

1 month 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.

**Division**

Research and Development / Global Drug Development /

Worldwide Patient Safety/ Safety Evidence and Sciences/ Submissions and Operational Excellence

**Functional Area Description**

The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines through 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**

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 data for signal detection and safety data review
- Execute literature searches and retrieve and deliver full-text articles
- Safety Data Review Meeting (SDRMs) support and logistics

**Signal Documentation and Notifications**
- Generates reports and upload into Signal Tracker
- Quality Check (QC)

**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, Document Management System)
- 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**
- Obtain Exposure data and update document
- Generate and file supporting data
- Support literature searches and deliver full-text articles

**Document Compliance, Management, Support**
- Transferring data into reports
- Formatting
- Querying follow up
- Closing, filing, tracking

**Other Activities**
- Manage data received in PV mailbox
- Update signal detection lists (e.g., Monitored events, Literature search terms, etc.) related MedDRA upgrades

**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.

**Operational Skills**:

- Technical Proficiency: Basic use of standard operational software and tools for automation.
- Process Management: Understanding of current processes and ability to evaluate and suggest digital improvements.
- Problem-Solving: Addresses straightforward problems with simple digital solutions.

**Analytical Skills**:

- Data Management: Processes and records data and information in structured computer readable formats
- Critical Thinking: Identifies flaws and inconsistencies in data or business processes by considering the system wide impact
- Data Analysis: Can perform basic data gathering and reporting using standard tools.

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

**On-site Protoc

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