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.
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Boulder | Denver | Westminster |Connecticut :
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Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
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Frank Scottile Blvd |Missouri :
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Basel | Zurich |Serbia :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
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Norway | NOrway |Romania :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
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Zagreb |Estonia :
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Japan | Saitama |Tokyo :
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Turku |Remote Korea :
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Seoul |Kazakhstan :
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Bucharest |Buenos Aires :
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Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
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Santiago |Bosnia and Herzegovina :
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