Periodic Report Specialist Jobs at Amgen

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:

• 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

Application Link