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
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 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.
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.
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.
- Location: Hyderabad – TS – IN
- Job ID: R1582630