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Associate Manager - Aggregate Report Writing

Elanco
Elanco
3+ years
₹10–15 LPA
10 July 7, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Associate Manager – Aggregate Report Writing
Location: Bangalore, India
Job Type: Full-time
Company: Elanco Animal Health
Requisition ID: R0022496
Application Deadline: July 14, 2025
Estimated Salary: ₹10–15 LPA (based on experience and industry standards)


Overview:
Elanco is hiring an Associate Manager – Aggregate Report Writing to join its Regulatory/R&D team in Bangalore. This role supports global pharmacovigilance operations by preparing regulatory-compliant aggregate reports, performing literature reviews, and collaborating with global teams to ensure data accuracy and timely submission.


Key Responsibilities:

  • Author aggregate reports (e.g., PBRERs, DSURs) in compliance with internal timelines and regulatory standards

  • Proofread self-authored documents prior to Quality Check review

  • Perform structured literature searches, extract sales data, and generate line listings

  • Ensure compliance with internal tools (e.g., Veeva Vault RIM), SOPs, and training documentation

  • Support regulatory and R&D initiatives through cross-functional collaboration

  • Maintain audit readiness and contribute to continuous improvement

  • Execute additional pharmacovigilance support tasks as needed


Minimum Qualifications:

  • Graduate in Veterinary Medicine or Postgraduate in Pharmacy/Life Sciences

  • Minimum 3 years of industry experience in pharmacovigilance or medical writing

  • Strong knowledge of GxP (GCP, GMP, GLP) and global regulatory guidelines

  • Proficient in Microsoft Office tools

  • Excellent written and verbal communication skills in English

  • Ability to work independently and across multiple time zones and geographies


Key Competencies:

  • Technical writing and document quality review

  • Familiarity with regulatory documentation processes

  • Global collaboration and cross-functional teamwork

  • Initiative-driven, detail-oriented, and deadline-focused