Product Safety Manager

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: Product Safety Manager - Signal Detection and Data Assembly Team

As a Product Safety Manager within the Global Pharmacovigilance team, you will be responsible for the compilation, review, validation, and analysis of safety data from internal and external sources to ensure the availability of high-quality evidence for robust benefit-risk assessments of non-High Profile Products (non-HPPs).

The primary responsibility of this role is to conduct systematic surveillance and review of scientific literature to identify, assess, and document safety information related to medicinal products. The role supports regulatory compliance, signal detection activities, and ongoing benefit-risk evaluation by ensuring that relevant adverse event reports, emerging safety concerns, and published safety data are accurately identified, evaluated, and communicated to appropriate pharmacovigilance stakeholders.

Additionally, the role provides support for other global pharmacovigilance activities, including aggregate report preparation, safety case review, and sales data compilation, as required, to support comprehensive safety assessments and regulatory submissions.

Your Responsibilities:

• Conduct literature surveillance and critical review activities to support signal detection, safety monitoring, and aggregate report preparation.
• Identify, evaluate, and document safety information from scientific and medical literature in accordance with pharmacovigilance requirements.
• Assess and communicate relevant adverse event reports, emerging safety concerns, and published safety data to support pharmacovigilance decision-making and regulatory compliance.
• Support benefit-risk evaluations through the analysis, interpretation, and synthesis of published safety data, ensuring high-quality documentation and timely completion of literature review activities.
• Collaborate with cross-functional stakeholders to support safety assessments, risk evaluations, and regulatory reporting requirements.
• Author and review aggregate reports and other regulatory safety documents, including Annual Signal Management Reports and Benefit-Risk Safety Reports, in compliance with applicable regulatory requirements.
• Manage and complete Veeva Vault RIM activities and workflows in a timely and compliant manner.
• Partner with Regulatory Affairs, PV Affiliates, and other functional teams to gather relevant data, ensure consistency of content, and facilitate effective communication with global affiliates and regulatory authorities, as required.
• Ensure pharmacovigilance documentation, processes, and records are inspection- and audit-ready, and support regulatory inspections and audits when applicable.
• Foster a positive and collaborative work environment aligned with organizational objectives, proactively aligning individual and team activities with company goals while encouraging others to do the same.

What You Need to Succeed (minimum qualifications):

• Education: Graduation in veterinary medicine/ post-graduation in pharmacy or any other life science background.
• Experience: A minimum of 1 - 3 years of industry experience in PV or medical writing.
• Excellent oral and written communication skills with ability to communicate logically and technically with global stakeholders.
• High competency in Microsoft Office applications.
• In-depth knowledge of GxP requirements and regulatory guidelines with sound understanding of operational Regulatory and R&D principles.

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

• Strong understanding of medical terms, clinical concepts, and their relevance in adverse event case reporting from medical literature.
• Understanding of aggregate report requirements and types of aggregate reports.
• Ability to work independently or as part of a team and collaborate with global teams cross geographies and time zones.
• Experience with electronic document management systems (e.g., Veeva Vault), Mastery of templates, styles, and submission-ready formatting.

Additional Information:

• Travel percentage up to 10%, annually.
• Location: Global, India- Bangalore

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

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.