Analyst - GDPS

Elanco; Bengaluru; On-site; INR 600,000 - 900,000; Full time

Job summary

Elanco is seeking an Analyst-GDPS in Bangalore, India to oversee data entry, seriousness assessment and causality of adverse event reports in the PV database. You will identify delays, escalate issues, and build knowledge of global PV regulations while ensuring timely case processing and submission to regulatory authorities.

The role requires veterinary qualifications (US DVM) or M. Pharm with PV experience, with 0–2 years preferred. Travel is minimal; location is Bangalore, India.

Qualifications

• Degree with pharmacovigilance basics
• Experience in handling adverse event reports is a plus
• Familiarity with PV regulations and case processing workflows

Responsibilities

• Enter data and assess seriousness and causality of adverse events in PV database
• Identify issues causing delays and escalate to management
• Develop understanding of pharmacovigilance regulations
• Meet internal timelines for case processing and submission to authorities
• Perform data quality checks and ensure completeness and accuracy

Skills

Data entry

Pharmacovigilance

Regulatory awareness

Communication skills

Time management

Education

Veterinarian (US DVM)

M. Pharm with pharmacovigilance experience

Tools

PV databases

Job description

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today!

Your Role:

Analyst-GDPS

Your Responsibilities:

• 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, reportability's 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.

Key Technical Responsibilities:

• Basic knowledge of medical terminologies and able to understand common medical terms relevant to pharmacovigilance and adverse event reporting.
• Effective verbal and written communication skills to liaise with internal and external stakeholders.
• Ability to work effectively on multiple products and effectively manage priorities.
• Ability to establish and maintain effective working relationships with coworkers, managers and relevant stake holders.
• Capable of adhering to applicable, global, local regulatory requirements.
• Skill in using multiple databases. Ability to support during high volumes and flexibility to work extended hours when required. Self-motivated, flexible, and receptive to changes.

What You Need to Succeed (minimum qualifications):

Veterinarian (equivalent to US DVM degree) with or without pharmacovigilance experience and M. Pharm with Pharmacovigilance Experience

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

0-2 years of pharmacovigilance experience.

Additional Information:

• Travel: 0%
• Location: India, Bangalore

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

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