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