Product Safety Manager

• 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.

• 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.

• →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.

• 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!

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