Bristol Myers Squibb job vacancy for Associate, Pharmacovigilance at Hyderabad

Associate, Pharmacovigilance

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

Apply medical, life science and general scientific knowledge and expertise to effectively support the following:

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.

Ideal Candidates Would Also Have:

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

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