Elanco is hiring for the position of Analyst – PV Case Processing in Bangalore. The role focuses on pharmacovigilance case processing, including adverse event data entry, seriousness and causality assessment, case quality checks, follow-up activities, and compliance with pharmacovigilance regulations and submission timelines.
Job Details
| Details | Information |
|---|---|
| Company | Elanco |
| Job Title | Analyst – PV Case Processing |
| Location | Bangalore, India |
| Job Type | Full Time |
| Job Requisition ID | R0026759 |
| Experience | 0–2 years of pharmacovigilance experience for eligible Life Sciences graduates |
Position
Analyst – PV Case Processing
The Analyst will manage adverse event reports and support accurate, complete, and compliant pharmacovigilance case processing. The position involves assessing cases, maintaining data quality, meeting regulatory timelines, and ensuring cases are ready for submission to appropriate regulatory authorities.
Responsibilities
- Perform data entry, seriousness assessment, and causality assessment of adverse event reports in the PV database.
- Validate data entered against source documents and call notes.
- Assess adverse event reports for seriousness, reportability, and causality, including the reason for assessment.
- Perform self-review to ensure completeness, correctness, and quality of case data.
- Ensure cases are complete, accurate, and ready for submission to appropriate regulatory authorities.
- Identify issues that could delay submission and escalate them to management when appropriate.
- Determine whether additional follow-up information is required.
- Comply with internal and external timelines for adverse event and product complaint case processing and submission.
- Develop an understanding of pharmacovigilance regulations.
- Meet expected productivity and quality standards.
- Participate actively in team meetings.
- Support multiple products and manage priorities effectively.
- Perform other duties as assigned.
Eligibility / Qualifications
Candidates must meet one of the following qualifications:
- Veterinarian, equivalent to a US DVM degree, with or without pharmacovigilance experience; or
- Bachelor’s degree in a Life Sciences-related field with 0–2 years of pharmacovigilance experience.
Required Skills
- Basic knowledge of medical terminology relevant to pharmacovigilance and adverse event reporting.
- Effective verbal and written communication skills.
- Ability to work across multiple products and manage priorities.
- Ability to maintain effective working relationships with coworkers, managers, and relevant stakeholders.
- Ability to adhere to applicable global and local regulatory requirements.
- Ability to use multiple databases.
- Ability to support high-volume workloads and work extended hours when required.
- Self-motivated, flexible, and receptive to change.
Application Details
