Meta Title:
Periodic Report Specialist – Pharmacovigilance | Hyderabad
Meta Description:
Join Amgen in Hyderabad as a Periodic Report Specialist. Author global safety reports like DSUR, PSUR. Competitive compensation, full-time on-site role.
Meta Keywords:
Pharmacovigilance jobs India, aggregate safety reports, DSUR writing, PSUR authoring, PBRER, drug safety specialist, Amgen careers, PV report writing, medical writing jobs Hyderabad, life sciences jobs India
Job Title: Periodic Report Specialist – Pharmacovigilance
Location: Hyderabad, India
Work Mode: On-site
Job Type: Full-Time
Category: Drug Safety / Pharmacovigilance / Medical Writing
Compensation: Competitive base salary plus Total Rewards Plan (as per local pharma industry standards)
Job Summary
Amgen is seeking a skilled Periodic Report Specialist to join its Global Safety team in Hyderabad. In this role, you will contribute to the preparation and management of Periodic Aggregate Safety Reports (PASRs) such as DSUR, PSUR, PBRER, and PADER in compliance with international pharmacovigilance regulations. This is a career-defining opportunity for individuals with a background in pharmaceutical safety writing, drug safety, or medical documentation, looking to grow with a biotech leader.
Key Responsibilities
Compile, author, and quality-check aggregate safety reports (DSUR, PSUR, PBRER, PADER, SSUR, Device PSUR, etc.)
Collaborate with Therapeutic Area Safety Scientists and cross-functional teams for report contributions
Manage timelines, coordinate stakeholder meetings, and ensure timely submissions
Author safety narratives and sections, review peer submissions, and initiate approval workflows
Ensure compliance with global pharmacovigilance standards (ICH-GVP)
Archive documentation and manage global distribution to CROs and Business Partners
Contribute to audit readiness and inspection support
Generate and monitor KPIs and KCIs for reporting operations
Stay updated with regulatory changes, safety regulations, and documentation standards
Required Skills & Qualifications
Education:
Master’s in Life Sciences + 1–3 years of experience
Bachelor’s in Life Sciences + 3–5 years of experience
Diploma + 7–9 years of experience
Preferred: Health Care Professional with 2–3 years of PASR writing experience
Technical Skills:
Expertise in authoring DSUR, PSUR, PBRER, PADER
Knowledge of Pharmacovigilance regulations and global safety standards
Familiarity with MedDRA, GVP, ICH guidelines
Strong command of English (written/oral)
Skilled in Microsoft Word, Excel, PowerPoint, Adobe Acrobat, SharePoint, Veeva Vault
Working knowledge of AI tools and prompts is a plus
Soft Skills:
Strong analytical judgment, attention to detail
Time and project management capabilities
Ability to operate in collaborative and cross-functional settings
Adaptability in a fast-paced, deadline-driven environment
Perks & Benefits
Competitive compensation aligned with industry benchmarks
Comprehensive Total Rewards Plan
Inclusive, science-driven, award-winning work culture
Global exposure and collaboration with international teams
Career advancement and continuous learning opportunities
Full compliance support and onboarding
Company Description
Amgen is a global biotechnology pioneer focused on unlocking the potential of biology for patients suffering from serious illnesses. With a legacy of innovation in Oncology, Inflammation, General Medicine, and Rare Diseases, Amgen blends cutting-edge science with a deep commitment to advancing human health through transformative therapies.
Work Mode
On-site – Hyderabad, India
Call to Action
Are you passionate about pharmacovigilance and global drug safety writing?
Apply now to join Amgen’s Hyderabad team and play a vital role in delivering life-saving information to global health authorities.
Explore your career at: careers.amgen.com
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