job title: Analyst - pharmacovigiilance (elanco)

Roles and Responsibilities

Your Role: Analyst – PV Case Processing

As an analyst in PV Case Processing, you will be responsible for managing adverse event reports, ensuring data accuracy, and maintaining compliance with global pharmacovigilance regulations and timelines. The role involves data entry, assessing seriousness and causality, and ensuring the completeness and quality of cases for regulatory submission. Effective communication skills, knowledge of regulations, and the ability to manage multiple priorities are essential. The Analyst must demonstrate Elanco core values, adaptability, and commitment to high-quality standards in all tasks.

Your Responsibilities:

• Responsible for data entry, seriousness assessment and causality assessment of adverse event reports in the PV database

• Identify 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 and 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.

What You Need to Succeed (minimum qualifications):

• Veterinarian (equivalent to US DVM degree) with or without pharmacovigilance experience; or Master’s degree in Life Sciences related field with 0-2 years of pharmacovigilance experience.

• Strong stakeholder communication, Effective multitasking and adaptability, Regulatory and systems proficiency

What will give you a competitive edge (preferred qualifications):

• Familiarity with veterinary PV and safety databases

• Excel skills (advanced excel, pivot tables, Power Query) and basic understanding of tools like Power BI or SQL for data handling.

• Exposure to E2B submissions and XML files adds value.

Additional Information:

• Travel: No travel needed

• Location: IN, Bangalore - Hybrid Work Environment