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Are you a life sciences professional with expertise in pharmacovigilance and regulatory safety reporting? Amgen, a global biopharmaceutical leader, is hiring a Periodic Report Specialist in Hyderabad, India. This role offers a unique opportunity to contribute to global drug safety through authoring, compiling, and reviewing Periodic Aggregate Safety Reports (PASRs) such as DSUR, PBRER/PSUR, PADER, Device PSUR, and country-specific reports. If you have strong writing skills, regulatory knowledge, and experience in safety documentation, this position is tailored for you.
Key Responsibilities
As a Periodic Report Specialist at Amgen, you will:
- Compile and author Periodic Aggregate Safety Reports (PASRs) including DSUR, PBRER/PSUR, SSUR, PADER/PAER, Device PSUR, and global submissions.
- Coordinate with cross-functional stakeholders and business partners to gather inputs and ensure compliance with regulatory timelines.
- Author safety content in collaboration with Therapeutic Area Safety Scientists.
- Conduct peer quality checks (QC) and manage review workflows.
- Archive accurate records, approve published versions, and distribute reports to CROs and Business Partners.
- Maintain up-to-date knowledge of global regulatory guidelines and reporting standards.
- Generate PASR metrics such as Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs).
- Assist with Literature Management processes as required.
Qualifications
To be successful in this role, candidates should have:
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- A degree in Pharmacy, Life Sciences, or related fields.
- 2–5 years of experience in pharmacovigilance, regulatory affairs, or safety writing.
- Strong knowledge of ICH, EMA, FDA, and country-specific safety reporting regulations.
- Excellent medical writing, communication, and documentation skills.
- Ability to work under strict timelines with cross-functional teams.
Benefits of Joining Amgen
- Opportunity to work with a world-leading biopharma company.
- Exposure to global safety reporting and regulatory submissions.
- Competitive salary package (₹6–12 LPA depending on experience).
- Professional growth in pharmacovigilance and regulatory safety writing.
- Collaborative and innovation-driven work culture.
How to Apply
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