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Global Pv Scientist

9+ years
Not Disclosed
10 July 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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 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.