Meta Title
Periodic Report Specialist – Amgen, Hyderabad
Meta Description
Join Amgen as a Periodic Report Specialist in Hyderabad. Contribute to global safety reports and PV compliance. Competitive compensation and benefits.
Meta Keywords
pharmacovigilance jobs India, aggregate safety reporting, periodic report specialist, medical writing pharma, PV specialist jobs Hyderabad, Amgen careers, DSUR PBRER PSUR, PV compliance, drug safety reporting, life sciences jobs
Periodic Report Specialist – Amgen (On-site, Hyderabad)
Job Summary
Amgen is seeking an experienced Periodic Report Specialist to support the authoring, compilation, and review of global Periodic Aggregate Safety Reports (PASRs) including DSURs, PBRERs, PSURs, and PADERs. This on-site position in Hyderabad, India, is perfect for professionals with a background in pharmacovigilance, regulatory writing, and aggregate report compliance. Be part of a science-driven, mission-focused team committed to improving patient outcomes.
Key Responsibilities
Compile and author a range of global safety reports (DSUR, PBRER, PSUR, PADER, etc.)
Coordinate and lead PASR meetings and cross-functional collaboration
Author and peer-review safety content in collaboration with Therapeutic Area Safety Scientists
Ensure compliance with global regulatory timelines and guidelines
Manage workflows, initiate approvals, and maintain audit-ready documentation
Support audit and inspection deliverables and Quality Management System adherence
Generate metrics, KPIs, and performance indicators for reporting processes
Maintain current knowledge of international PV guidelines and standards
Required Skills & Qualifications
Education:
Master’s with 1–3 years of PV/medical writing experience
OR Bachelor’s with 3–5 years
OR Diploma with 7–9 years
Essential Skills:
Strong knowledge of pharmacovigilance regulations, aggregate reporting, DSUR, PBRER, PSUR
Proficiency in scientific/medical writing, peer review, and report authoring
Understanding of GVP, ICH-GCP, and international regulatory requirements
Skilled in MS Word, PowerPoint, Excel, Adobe Acrobat, SharePoint, Veeva Vault
Experience using AI tools and prompt engineering is a plus
Excellent communication, organizational, and cross-functional collaboration skills
Detail-oriented, strategic thinker with strong project management capabilities
Preferred Qualifications
Bachelor’s/Master’s in Health or Life Sciences
2+ years of aggregate safety report writing experience across therapeutic areas
Exposure to global regulatory submissions and inspection readiness processes
Perks & Benefits
Competitive base salary (exact range not disclosed)
Comprehensive Total Rewards Plan aligned with local pharma benchmarks
Inclusive, ethical, and innovative workplace culture
Global career opportunities and development programs
Health and wellness benefits
Opportunities to engage in cutting-edge PV practices
Company Description
Amgen is a global leader in biotechnology, transforming the treatment of serious illnesses through innovation in oncology, inflammation, general medicine, and rare diseases. With a deep commitment to patient care and safety, Amgen continues to lead in pharmacovigilance and regulatory excellence.
Work Mode
On-site – Hyderabad, India
Call to Action
If you're ready to elevate your pharmacovigilance career and be part of a team that makes a global impact, apply now through the Amgen Careers portal.
Join Amgen. Serve patients. Advance science. Transform your career.
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