Job Opportunity: Safety Specialist – Periodic Aggregate Safety Reports
Location: Hyderabad, India
Job ID: R-224802
Work Type: On-Site
Category: Safety
Date Posted: September 10, 2025
Role Overview
This position plays a key role in the authoring, compilation, and peer review of Amgen’s Periodic Aggregate Safety Reports (PASRs), ensuring compliance with global regulatory requirements and timely submissions. The role supports end-to-end report writing, documentation, and stakeholder collaboration.
Key Responsibilities
Periodic Aggregate Safety Reports (PASRs)
Compile and author reports such as DSUR, PBRER/PSUR, SSUR, PADER/PAER, Device PSUR, and country-specific submissions (e.g., Korea PSUR, Brazil PSUR, Colombia Annual Safety Reports).
Coordinate and schedule cross-functional stakeholder meetings for effective collaboration.
Drive report timelines; escalate risks or delays to leadership when needed.
Collect and compile inputs from cross-functional teams and external business partners.
Author safety content in collaboration with Therapeutic Area Safety Scientists.
Conduct peer quality control (QC) of safety-authored sections and manage review cycles.
Maintain accurate documentation and archiving throughout the reporting process.
Review and approve published report versions (blinded/unblinded; EU, FDA, Rest of World).
Manage report distribution to CROs and Business Partners.
Ensure compliance with regulatory guidelines, timelines, styles, and processes.
Perform peer/quality review of PASRs using appropriate checklists.
Stay updated on regulatory requirements, technological advances, and industry standards.
Generate PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs).
Literature Management
Provide support for Literature Management activities as needed.
Qualifications & Skills
Strong knowledge of global regulatory guidelines and safety reporting standards.
Experience in authoring and reviewing regulatory safety reports.
Ability to collaborate with cross-functional teams and external partners.
Detail-oriented with strong organizational and documentation skills.
Proficiency in managing timelines, risks, and compliance metrics.
✅ Apply Now to join Amgen’s global Safety team and contribute to advancing patient safety through high-quality regulatory reporting.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Ranchi |Sikkim :
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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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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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
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Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
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Dickinson |Minnesota :
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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 :
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Lake Charles | Shreveport |Nevada :
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Lisbon | Oeiras | Portugal |WI :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
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Rostock |Saarland :
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Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Wavre |Tipperary :
Ballydine |Cork :
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Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
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Wuhan |Capital of Netherland :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
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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 :
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 :
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Barcelona |Madrid :
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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 :
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Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
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Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
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New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Rabigh | Jeddah | Najran | King Abdullah Economic City | Riyadh | Khulais |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |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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