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Periodic Report Manager

6-8 years
Not Disclosed
10 June 6, 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

Meta Title:
Periodic Report Manager – Pharmacovigilance | Hyderabad

Meta Description:
Apply for Periodic Report Manager at Amgen, Hyderabad. Lead global pharmacovigilance reporting and ensure regulatory compliance. Full-time, on-site role.

Meta Keywords:
pharmacovigilance jobs, periodic safety update, aggregate report writing, DSUR, PSUR, PBRER, PV operations, Hyderabad biotech jobs, drug safety careers India


Job Summary

Amgen, a global leader in biotechnology, is hiring a Periodic Report Manager for its Hyderabad, India location. This on-site role is ideal for experienced pharmacovigilance professionals who specialize in the preparation, authorship, and quality review of Periodic Aggregate Safety Reports (PASRs) such as DSURs, PBRERs, PSURs, and more. You will manage a team of report specialists and ensure compliance with global regulatory standards while driving operational excellence and inspection readiness.


Key Responsibilities

  • Manage and supervise a team of Periodic Report Specialists

  • Coordinate and author global safety reports including DSUR, PBRER, PSUR, PADER, and regional submissions

  • Ensure adherence to ICH-GVP and international regulatory requirements

  • Lead cross-functional meetings and align stakeholders on report timelines

  • Conduct quality review of safety sections and initiate approval workflows

  • Oversee documentation, archiving, and distribution processes

  • Maintain inspection readiness and support audits or regulatory reviews

  • Generate key performance and compliance metrics for safety reports


Required Skills and Qualifications

  • Master’s degree with 4–6 years OR Bachelor’s degree with 6–8 years of experience in pharma, biotech, or regulatory settings

  • In-depth knowledge of MedDRA, ICH-GVP, global PV regulations, and aggregate safety reporting

  • Proven experience in writing and reviewing DSURs, PBRERs, PSURs, and related reports

  • Strong communication, project management, and analytical skills

  • Proficiency with MS Word, Excel, PowerPoint, Adobe Acrobat, SharePoint, Veeva Vault

  • Experience using AI tools and digital platforms is preferred

  • Prior leadership experience or team oversight in safety writing roles

  • Health care professional background is highly desirable


Perks and Benefits

  • Competitive base salary and total rewards package aligned with industry standards

  • Professional development and training opportunities

  • Inclusive and collaborative work environment

  • Contribution to impactful global healthcare initiatives

  • Full-time, stable position with long-term career growth


Company Description

Amgen is one of the world’s leading biotechnology companies, committed to discovering, developing, and delivering innovative medicines to help patients with serious illnesses. Operating globally in areas such as Oncology, Inflammation, and Rare Diseases, Amgen combines science and technology to serve millions of patients worldwide.


Work Mode: On-Site (Hyderabad, India)


Call to Action

Ready to advance your career in global drug safety and pharmacovigilance? Join Amgen as a Periodic Report Manager and make a difference in patient lives.
Apply today at
careers.amgen.com