Job Summary:
Amgen is seeking an experienced Global PV Scientist to join its pharmacovigilance team in Hyderabad, India. This role is pivotal in enhancing drug safety through signal detection, aggregate report preparation, safety data evaluation, and risk management strategy. Ideal for professionals with 9+ years of pharmacovigilance experience, this position supports global safety operations for clinical and post-marketing programs.
Key Responsibilities:
Prepare and review non-medical sections of aggregate safety reports
Coordinate with global affiliates and internal teams on deliverables
Review adverse event (AE) and serious adverse event (SAE) reports from clinical trials
Provide input on study protocols, SAPs, and safety data tables
Conduct safety signal detection, evaluation, and documentation
Collaborate with Global Safety Officers (GSO) for risk assessments
Draft safety assessment reports and regulatory safety responses
Assist in preparation and updates of risk management plans (RMPs)
Evaluate and track risk minimization activities
Contribute to safety sections of regulatory filings and submissions
Participate in safety governance and cross-functional reviews
Ensure inspection readiness and participate in internal/external audits
Required Skills & Qualifications:
Bachelor’s or Master’s degree in life sciences or healthcare discipline
Minimum 9 years of relevant pharmacovigilance or drug safety experience
Solid knowledge of global PV regulations (GVP, ICH-GCP)
Familiarity with MedDRA coding, case processing, and safety databases
Experience with signal detection and risk management documentation
Strong analytical, writing, and communication skills
Inspection readiness and regulatory response experience preferred
Perks & Benefits:
Work with a globally renowned biopharmaceutical leader
Exposure to cross-functional and global safety operations
Supportive team environment with ongoing learning opportunities
Competitive compensation and benefits (exact salary not disclosed)
Opportunity to contribute to patient safety globally
Company Description:
Amgen is a global biotechnology pioneer committed to unlocking the potential of biology for patients suffering from serious illnesses. With a robust portfolio and global safety operations, Amgen empowers its teams to innovate across therapeutic areas.
Work Mode:
On-site – Hyderabad, India
Call-to-Action:
Ready to advance your career in global pharmacovigilance? Apply now for the Global PV Scientist position at Amgen and be part of a mission-driven team dedicated to patient safety.
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