Your Role: Analyst – PV
Your Responsibilities: –
1. Adverse Event Case Processing –
- Responsible for data entry, seriousness assessment and causality assessment of adverse event reports in the PV database
- Identifies issues in case processing that may result in a delay in submission and escalates issues to management as appropriate.
- Develop an understanding of pharmacovigilance regulations.
- Comply with internal and external timelines for managing adverse events and product complaint case processing and case submission processes as appropriate.
- Typical case processing activities include (but not limited to):
- Validation of data entry against source document(s) and call notes as appropriate.
- Assessment of adverse event reports for seriousness, reportabilities and causality including reason for assessment.
- Perform self-review of all data for completeness, correctness and quality.
- Ensuring that the case is considered complete, accurate, and ready for submission to appropriate regulatory authorities.
- Determine what, if any, follow-up information is needed
- Ensure to meet the expected productivity and quality standards.
- Active participation in team meetings.
- Perform other duties as assigned.
Skills & Abilities
- Basic knowledge of medical terminologies and able to understand common medical terms relevant to pharmacovigilance and adverse event reporting.
2. Global GPV Support
- Keep current on global regulatory issues and practices related to GPV
- Assist with support of internal partners in GPV related activities as necessary
- Partner and communicate with GPV colleagues
- Management of global adverse events mailbox
- Perform regulatory submissions of individual case reports
3. Collaboration/Support Internal and External Customers
- Communicate effectively with Elanco contacts from affiliate offices, call center contacts, legal, customer response teams, and other customer groups
- Understand the confidential nature of company information and take necessary steps to ensure its protection
- Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to outside parties
What You Need to Succeed (minimum qualifications):
- 0-2 years of experience in PV
- Basic understanding of PV Case processing, Study Literature
- High Learning Agility
- Good Communication Skills
What will give you a competitive edge (preferred qualifications):
- Experience working on Pharmacovigilance (PV) case processing
Additional Information:
- Travel: 0%
- Location: India, Bangalore
