Elanco is hiring for an Analyst – PV Case Processing role in Bangalore, India. The position focuses on adverse event case processing, data entry, seriousness and causality assessment, case quality, and compliance with pharmacovigilance regulations and timelines.

Job Details

Analyst – PV Case Processing: Responsibilities

Adverse Event Case Processing

• Perform data entry, seriousness assessment and causality assessment of adverse event reports in the PV database.
• Identify case-processing issues that may delay submissions and escalate them to management when appropriate.
• Develop an understanding of pharmacovigilance regulations.
• Comply with internal and external timelines for adverse event and product complaint case processing and submissions.
• Validate data entry against source documents and call notes where appropriate.
• Assess adverse event reports for seriousness, reportability and causality, including the reason for assessment.
• Perform self-review of data for completeness, correctness and quality.
• Ensure cases are complete, accurate and ready for submission to appropriate regulatory authorities.
• Determine whether additional follow-up information is required.
• Meet expected productivity and quality standards.
• Participate actively in team meetings.
• Perform other assigned duties.

Key Technical Responsibilities

• Apply basic knowledge of medical terminology relevant to pharmacovigilance and adverse event reporting.
• Communicate effectively with internal and external stakeholders.
• Manage multiple products and priorities effectively.
• Establish and maintain effective working relationships with coworkers, managers and relevant stakeholders.
• Adhere to applicable global and local regulatory requirements.
• Work with multiple databases.
• Support case processing during high-volume periods.
• Work extended hours when required.
• Demonstrate flexibility and adaptability to changes.

Eligibility & Qualifications

The minimum qualifications are:

• Veterinarian, equivalent to a US DVM degree, with or without pharmacovigilance experience; or
• M. Pharm with Pharmacovigilance experience.

Preferred Experience

• 0–2 years of pharmacovigilance experience.

Required Skills

Candidates should have:

• Knowledge of medical terminology relevant to pharmacovigilance and adverse event reporting.
• Understanding of pharmacovigilance regulations.
• Data entry and adverse event case-processing skills.
• Ability to assess seriousness, reportability and causality.
• Strong verbal and written communication skills.
• Ability to manage multiple products and priorities.
• Ability to work with multiple databases.
• Attention to completeness, correctness and quality.
• Ability to meet productivity and quality standards.
• Flexibility and adaptability.
• Ability to work effectively with internal and external stakeholders.

Application Details

Application Link