Amgen Hiring Sr. Associate Pharmacovigilance Operations

Amgen Hiring Sr. Associate – Pharmacovigilance Operations | B Pharm / M.Pharm / Life Sciences | 5-9 Years | Hyderabad Location

Apply for Sr. Associate Pharmacovigilance Operations at Amgen in Hyderabad. Candidates with B Pharm/M.Pharm/Life Sciences and 5-9 years of experience in PASR writing are eligible.

Opportunity in Pharmacovigilance at Amgen, Hyderabad

Amgen, a global biopharmaceutical leader, is actively seeking a Sr. Associate – Pharmacovigilance Operations to join its Hyderabad team. This role is ideal for professionals with strong experience in pharmacovigilance report writing and a passion for global regulatory compliance.

About Amgen India

Amgen is renowned worldwide for its cutting-edge research and biopharmaceutical innovation. The Hyderabad location supports global operations in safety, regulatory, and R&D functions, providing a collaborative and impactful work environment.

Role Overview: Sr. Associate – Pharmacovigilance Operations

Job Location

• Hyderabad, Telangana, India
• On-site Role

Educational Qualifications

• Bachelor’s or Master’s degree in Life Sciences or Pharmacy

Experience Required

• Total experience: 5–9 years
• Minimum 2–3 years in Periodic Aggregate Safety Report (PASR) writing

Key Responsibilities

• Compile and author various PASRs including DSUR, PBRER/PSUR, SSUR, PADER, and country-specific reports (e.g., Korea PSUR, Brazil PSUR)
• Collaborate with cross-functional stakeholders for data gathering
• Coordinate report timelines and ensure regulatory compliance
• Conduct peer review/quality control of safety content
• Archive and manage documentation workflows
• Distribute final reports to CROs and global partners
• Generate and monitor safety KPIs and compliance metrics

Required Skills and Competencies

Pharmacovigilance Expertise

• Knowledge of global safety report types (DSUR, PSUR, PADER, etc.)
• Familiarity with regulatory guidelines and medical writing standards

Collaboration & Documentation

• Strong cross-functional coordination
• Peer QC and stakeholder comment resolution

Compliance & Reporting

• Ensure all safety documents meet regulatory timelines and formats
• Maintain awareness of evolving pharmacovigilance and regulatory landscapes

Bonus Skill

• Literature management involvement is a plus

How to Apply?

Interested and qualified candidates may apply directly via the official Amgen careers portal: Apply Now

Job Snapshot Table

Company Name	Current Vacancies	Required Education	Experience Required
Amgen	Sr. Associate – Pharmacovigilance	B Pharm / M.Pharm / Life Sciences	5–9 Years

Amgen is hiring Sr. Associate Pharmacovigilance Operations in Hyderabad for professionals with 5–9 years of experience in PASR writing. Apply now!