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Global Pv Scientist

9+ years years
Not Disclosed
10 Sept. 2, 2025
Job Description
Job Type: Full Time Education: Master’s or Bachelor’s degree Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Global PV Scientist


Job Details:

  • Job ID: R-221539

  • Location: India – Hyderabad

  • Work Location: On-site

  • Date Posted: July 25, 2025

  • Category: Safety

  • Company: Amgen


Role Overview:

The PV Scientist Manager contributes to pharmacovigilance activities including planning, preparation, and review of safety reports and data. The role involves collaboration with internal teams and affiliates, supporting safety signal detection and evaluation, and assisting in risk management and regulatory filings.


Key Responsibilities:

Aggregate Reporting & Clinical Study Support

  • Plan, prepare, write, and review non-medical sections of aggregate safety reports

  • Collaborate with affiliates and internal partners on deliverables

  • Review adverse events (AE/SAEs) from clinical trials as required

  • Provide input on study protocols, statistical analysis plans, and related clinical documents under the guidance of the Global PV Sr. Scientist or Lead

  • Review standard tables, figures, and listings for clinical safety data

  • Participate in designing safety data collection forms for clinical studies

  • Attend study team meetings as needed

Signal Detection & Safety Evaluation

  • Conduct signal detection, evaluation, and management

  • Perform data analysis for safety signals and collaborate on reporting results

  • Prepare safety assessment reports, regulatory responses, and other safety documents

  • Search and review AE data, literature, and other safety-relevant data for signal detection

  • Participate in Safety Governance per Amgen processes

  • Present safety recommendations to cross-functional decision-making bodies

Risk Management

  • Support the development of risk management strategies and plans

  • Provide content for risk management plans and update regional plans

  • Assist in overseeing and evaluating risk minimization activities and track progress

  • Prepare responses to regulatory inquiries related to risk management under GSO guidance

Regulatory Support

  • Support new drug applications and regulatory filings with safety content

  • Assist in developing safety-related regulatory strategies

  • Provide safety-related content for regulatory submissions

Inspection Readiness

  • Undertake delegated activities from the QPPV as per PV System Master File

  • Maintain state of inspection readiness

  • Serve as point of contact for Health Authority inspections and internal audits within role scope

Process Improvement

  • Contribute to the development, standardization, and improvement of pharmacovigilance processes and methods

  • Participate in implementation of new processes within the Therapeutic Area


Basic Qualifications & Experience:

  • Master’s or Bachelor’s degree

  • Minimum 9+ years of relevant experience in pharmacovigilance or related fields


Apply Now

For further details and to apply, visit Amgen Careers.