Global PV Scientist Manager – Amgen
Location: Not Specified (Global Role, Remote Flexibility Possible)
Work Type: Full-time
Estimated Salary: ₹18–25 LPA (based on 9+ years of experience and global standards)
About the Role:
Amgen is seeking an experienced PV Scientist Manager to join its Global Patient Safety (GPS) team. This role involves strategic and hands-on contributions to aggregate report writing, signal detection, risk management planning, and safety governance. The PV Scientist Manager works closely with Global Safety Officers (GSOs), senior scientists, affiliates, and cross-functional teams to ensure regulatory compliance and enhance patient safety across the product lifecycle.
Key Responsibilities:
Aggregate Safety Reporting & Collaboration:
Plan, write, and review non-medical components of aggregate reports.
Liaise with global affiliates and internal stakeholders for safety deliverables.
Review adverse events (AE/SAEs) from clinical trials as required.
Clinical Development Safety Support:
Contribute to the review of study protocols, statistical analysis plans (SAPs), and other clinical study documents.
Participate in safety-related form development and study team meetings.
Review standard designs for safety tables, figures, and listings.
Signal Detection & Evaluation:
Conduct signal detection, management, and evaluation.
Perform safety data analysis and prepare written assessments.
Search literature, adverse event databases, and other sources for emerging safety signals.
Safety Governance & Risk Management:
Present safety assessments and recommendations to cross-functional governance bodies.
Assist in creating and updating Risk Management Plans (RMPs) and risk minimization strategies.
Prepare responses to regulatory inquiries related to RMPs.
Regulatory Support:
Provide safety content for New Drug Applications (NDAs) and other global submissions.
Support development of safety strategies for global filings and regulatory communications.
Inspection Readiness & Compliance:
Perform delegated QPPV-related duties per the PV System Master File.
Act as a point of contact during internal audits and regulatory inspections.
Maintain a continuous state of inspection readiness.
Process Improvement:
Contribute to the development and standardization of pharmacovigilance processes.
Support Therapeutic Area-specific implementation of new PV systems and methods.
Basic Qualifications:
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a relevant healthcare field.
Minimum 9+ years of experience in pharmacovigilance, clinical safety, or related drug development fields.
Strong experience in signal detection, risk management, and regulatory submissions.
Working knowledge of ICH-GCP, FDA, EMA, and global PV standards.
Ideal Candidate Attributes:
Proven cross-functional collaboration in a global regulatory environment.
Experience working with Health Authority inspections and inspection readiness planning.
Ability to drive strategic decision-making using data-driven safety insights.
Strong communication, analytical, and documentation skills.
Why Join Amgen?
Work with a leading biopharmaceutical company committed to innovation and global health.
Be part of a mission-driven culture that values patient safety and scientific excellence.
Access competitive global benefits, opportunities for leadership, and career advancement.
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