Analyst - R&D-1

Elanco; Bengaluru; Vor Ort; INR 600.000 - 900.000; Vollzeit

Zusammenfassung

Elanco Animal Health in Bengaluru is seeking an Analyst in PV Case Processing to manage adverse event reports, assess seriousness and causality, and ensure complete, accurate cases for regulatory submission.

You will work across multiple products, maintain compliance with global pharmacovigilance regulations, and collaborate with internal and external stakeholders to meet timelines and quality standards.

Qualifikationen

• Basic knowledge of medical terminologies relevant to pharmacovigilance.
• Strong verbal and written communication for internal and external stakeholders.
• Ability to manage multiple products and priorities effectively.

Aufgaben

• Process adverse event cases with data entry and seriousness assessment.
• Assess causality and ensure case completeness for regulatory submission.
• Identify issues causing delays and escalate to management as needed.
• Maintain compliance with global pharmacovigilance regulations and timelines.
• Perform self-review for data quality and prepare for submission.

Kenntnisse

Pharmacovigilance

Data entry

Seriousness assessment

Causality assessment

Regulatory compliance

Communication skills

Prioritization

Multitask management

Tools

PV database

Jobbeschreibung

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!

The Analyst in PV Case Processing is 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.

Functions, Duties, Tasks

Typical case processing activities include (but not limited to):

• Adverse Event Case Processing - 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.
• 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.

Skills & Abilities

• 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.

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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer.

For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet.

Learn more at www.elanco.com.