Periodic Report QC Reviewer
Location: Hyderabad, India
Job ID: R-216803
Posted On: June 04, 2025
Work Type: On-Site | Full-Time
Category: Safety
About the Role:
Amgen is hiring a Periodic Report QC Reviewer responsible for performing detailed quality control checks of Periodic Aggregate Safety Reports (PASRs) such as DSURs, PBRERs/PSURs, PADERs/PAERs, SSURs, Device PSURs, and country-specific reports (e.g., Korea PSUR, Brazil PSUR, Colombia Clinical Research Safety Reports). You will ensure compliance with global regulations, internal SOPs, and ensure content accuracy, data integrity, and format consistency across safety documents.
Key Responsibilities:
Quality Control:
Perform end-to-end QC of aggregate safety reports to verify narrative accuracy, proper table/data integration, formatting, and alignment with source data.
Ensure adherence to regulatory guidance, Amgen style guides, and report templates.
Identify and address discrepancies with the Periodic Report Specialists.
Maintain version control and detailed documentation of all QC activities.
Regulatory Compliance & Documentation:
Stay updated on evolving global pharmacovigilance regulations for PASRs.
Contribute to refining QC SOPs, templates, and checklists.
Support inspection readiness by ensuring traceable, audit-ready documentation.
Collaboration & Reporting:
Work closely with cross-functional teams to address QC findings in a timely manner.
Monitor QC metrics and assist in performance improvement initiatives.
Provide input to ensure timely and accurate report submissions.
Basic Qualifications:
Master’s degree with 1–3 years of relevant industry experience OR
Bachelor’s degree with 3–5 years of relevant experience OR
Diploma with 7–9 years of relevant experience in pharma, biotech, or regulatory research settings.
Preferred Qualifications:
Health Care Professional or Life Sciences graduate with 2–3 years of experience in periodic aggregate safety reporting.
Experience with DSURs, PBRERs/PSURs, PADERs, and familiarity with FDA, EMA, and other global regulatory requirements.
Exposure to Veeva Vault, SharePoint, or other document management systems.
Working knowledge of AI tools and prompts to streamline QC activities.
Strong command over scientific writing/editing, pharmacovigilance regulations, and aggregate safety reporting.
Skills Required:
Keen eye for detail and ability to spot content/data inconsistencies.
Solid understanding of pharmacovigilance concepts and safety documentation workflows.
Proficient in MS Office tools, Adobe Acrobat, and literature/database navigation.
Strong written and verbal communication skills in English.
Capable of handling multiple reports and priorities under tight deadlines.
Estimated Salary: ₹12–20 LPA (based on experience and regulatory documentation background)
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
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Pondicherry (Puducherry) |Jharkhand :
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Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Bangor | Brewer |New Jersey :
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Frank Scottile Blvd |Missouri :
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Tuscaloosa |D.C :
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Berlin |Baden-Wurttemberg :
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 :
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Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
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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 :
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Carlow |Republic of Ireland :
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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 :
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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 :
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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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Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
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Surabaya |Japan :
Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Seoul |Kazakhstan :
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Buenos Aires |Republic of Egypt :
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Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
King Abdullah Economic City | Khulais | Riyadh | Rabigh | Najran | Jeddah |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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