Job Title:
Medical Review Scientist
Job ID:
R-205810
Location:
India – Hyderabad
Work Location Type:
On Site
Date Posted:
February 4, 2025
Category:
Safety
About Amgen
Amgen is a global leader in biotechnology focused on four key therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. Since 1980, Amgen has delivered innovative medicines to help millions of patients live longer, healthier lives. The organization values collaboration, innovation, and science-driven outcomes with a mission to serve patients worldwide.
Role Summary
As a Medical Review Scientist, you will be responsible for conducting medical review of individual case safety reports (ICSRs) and supporting Amgen’s global pharmacovigilance operations. Your work ensures regulatory compliance and quality in safety surveillance activities.
Responsibilities
Perform medical review of ICSRs (narratives, coding, expectedness, causality, seriousness)
Ensure regulatory compliance for global ICSR reporting
Maintain medical validity of reports and act as key contact for Case Management
Support Medical Safety Review Team (MSRT) and provide input to list of expected terms in auto label tool
Conduct ICSR escalation and case follow-up per SOPs
Perform reportability assessments for medical device and product complaint-related events
Contribute to quality assurance, training, and mentoring junior reviewers
Participate in Safety Assessment Teams (SAT) as needed
Assist with process improvements, SOP development, and internal/external audits
Serve as point of contact during Health Authority Inspections and maintain inspection readiness
Basic Qualifications
MD/DO or international equivalent
AND
3 years of related drug safety experience
Knowledge of:
Amgen Medical Review and Case Management SOPs
Regulatory requirements in pharmacovigilance
Clinical trials and drug development
Amgen safety systems, databases, and medical coding
Clinical and post-marketing safety data capture
Preferred Qualifications
MD/DO or international equivalent
AND
4 years of relevant work experience
Familiarity with Amgen’s therapeutic areas and products
What You Can Expect from Amgen
A science-based, collaborative, and inclusive work environment
Competitive salary and Total Rewards Plans
Continuous learning and growth opportunities
A strong sense of mission to impact global patient health
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Siliguri |Illinois :
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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 :
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Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
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Bavaria |Bavaria :
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Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Rostock |Saarland :
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Basel | Zurich |Serbia :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
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Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
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Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Renfrew | Mississauga | North York | Australia | Richmond Hill | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Najran | Rabigh | Riyadh | Khulais | Jeddah | King Abdullah Economic City |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
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