Elanco is hiring for the position of Analyst – R&D in Bangalore. The role is focused on Pharmacovigilance (PV) Case Processing, including adverse event data entry, seriousness and causality assessment, case validation, follow-up assessment, and ensuring cases meet quality and regulatory submission requirements.

The position requires knowledge of medical terminology, pharmacovigilance regulations, effective communication, and the ability to manage multiple priorities while meeting productivity, quality, and regulatory timelines.

Job Details

Position

Analyst – R&D

The Analyst in PV Case Processing will manage adverse event reports, maintain data accuracy, and support compliance with global pharmacovigilance regulations and timelines.

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, as appropriate.
• Assess adverse event reports for seriousness, reportability, and causality, including the reason for assessment.
• Perform self-review of case data for completeness, correctness, and quality.
• Ensure cases are complete, accurate, and ready for submission to appropriate regulatory authorities.
• Determine whether follow-up information is required.
• Identify case-processing issues that could result in submission delays and escalate them to management when appropriate.
• Comply with internal and external timelines for adverse event and product complaint case processing and submission processes, as applicable.
• Meet expected productivity and quality standards.
• Develop an understanding of pharmacovigilance regulations.
• Participate actively in team meetings.
• Perform other duties as assigned.

Eligibility / Qualifications

The supplied job description requires candidates to have:

• Basic knowledge of medical terminology.
• Ability to understand common medical terms relevant to pharmacovigilance and adverse event reporting.
• Ability to adhere to applicable global and local regulatory requirements.

Required Skills

• Effective verbal and written communication skills.
• Ability to work across multiple products and manage priorities effectively.
• Ability to establish and maintain effective working relationships with coworkers, managers, and relevant stakeholders.
• Skill in using multiple databases.
• Ability to support during high-volume workloads.
• Flexibility to work extended hours when required.
• Self-motivated and flexible approach.
• Receptiveness to changes.
• Commitment to quality and applicable pharmacovigilance requirements.

Application Details