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Analyst - Pharmacovigilance
2 weeks ago
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. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.
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
Company Overview:
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. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet, and our enterprise.
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 – 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
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles
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
