Global PV Scientist – Pharmacovigilance | On-site | Hyderabad
Job Summary:
Amgen is hiring a highly experienced Global PV Scientist to join its Global Patient Safety team in Hyderabad, India. The role focuses on pharmacovigilance (PV) activities including aggregate report writing, signal detection, safety data analysis, and regulatory filings. The ideal candidate will bring 9+ years of experience in pharmacovigilance, with strong skills in data evaluation and safety documentation.
Key Responsibilities:
Prepare and review non-medical sections of aggregate safety reports.
Collaborate with affiliates and cross-functional partners for deliverables.
Review AE/SAEs from clinical trials and support study teams with safety input.
Contribute to protocols, statistical analysis plans, and clinical study documents.
Conduct signal detection, analysis, and safety assessments.
Prepare safety reports, risk management plans, and regulatory responses.
Participate in safety governance and decision-making forums.
Support development and oversight of risk minimization activities.
Prepare for and represent during audits and health authority inspections.
Assist in strategy and execution of safety-related content in drug filings.
Required Skills & Qualifications:
Bachelor’s or Master’s degree in Life Sciences or related field.
Minimum of 9 years of relevant experience in pharmacovigilance or drug safety.
Strong knowledge of signal detection, aggregate report writing, and risk management.
Familiarity with global regulatory guidelines (GVP, ICH, EMA, FDA).
Experience with safety data review and regulatory documentation.
Proficiency in literature search and adverse event data analysis.
Ability to work with cross-functional global teams.
Perks & Benefits:
Opportunity to work with a global biopharmaceutical leader.
Collaborative and innovation-driven work culture.
Exposure to global regulatory safety standards.
Career growth in pharmacovigilance and drug safety science.
Competitive compensation and benefits (not specified in job description).
Company Description:
Amgen is a global biotechnology leader committed to unlocking the potential of biology for patients suffering from serious illnesses. With a focus on innovative drug development, Amgen’s Hyderabad location serves as a hub for advancing pharmacovigilance and safety science globally.
Work Mode: On-site (Hyderabad, India)
Call to Action:
If you are a pharmacovigilance professional with strong experience in drug safety, data analysis, and regulatory documentation, apply now to be part of Amgen’s Global Patient Safety team in Hyderabad.
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