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
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