Senior Associate – Pharmacovigilance Operations
Department: Global Safety / Pharmacovigilance
Location: Hyderabad, India
Company: Amgen
Job ID: R-246911
Work Model: On-Site
Experience: 4–8 Years
Function: Aggregate Safety Reporting & Pharmacovigilance Operations
Role Summary
The Senior Associate – Pharmacovigilance Operations is responsible for the end-to-end coordination, compilation, authoring, quality review, and submission support of Periodic Aggregate Safety Reports (PASRs) in compliance with global regulatory requirements.
The role collaborates closely with Global Safety Scientists, Medical Writing, Regulatory Affairs, CROs, and external business partners to ensure timely delivery of high-quality safety reports supporting Amgen's global development and marketed product portfolio.
Key Responsibilities
1. Aggregate Safety Report Management
Coordinate preparation and delivery of:
Development Safety Update Reports (DSURs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Periodic Safety Update Reports (PSURs)
Semi-Annual Safety Update Reports (SSURs)
Periodic Adverse Drug Experience Reports (PADERs/PAERs)
Device PSURs
Country-specific aggregate reports (Korea, Brazil, Colombia, etc.)
Ensure reports are developed according to global regulatory timelines.
2. Report Authoring & Compilation
Author and compile safety sections of aggregate safety reports.
Consolidate inputs received from:
Safety Scientists
Medical Review Teams
Regulatory Affairs
Clinical Development Teams
CRO Partners
Ensure scientific accuracy, consistency, and completeness of safety content.
3. Cross-Functional Project Coordination
Schedule and coordinate meetings with stakeholders.
Track report development milestones.
Monitor project timelines and deliverables.
Escalate risks, delays, or resource constraints to management.
Facilitate effective communication among global teams.
4. Quality Control & Peer Review
Perform peer review and quality control checks of PASRs.
Verify:
Accuracy
Consistency
Regulatory compliance
Formatting standards
Data integrity
Utilize approved checklists and quality review procedures.
5. Regulatory Compliance & Submission Support
Ensure compliance with:
ICH Guidelines
GVP Modules
FDA Requirements
EMA Requirements
Local Regulatory Requirements
Support approval workflows and document finalization.
Review and approve published report versions before distribution.
6. Documentation & Inspection Readiness
Maintain complete and audit-ready documentation.
Archive all report-related records in compliance with SOPs.
Support regulatory inspections and internal audits.
Ensure traceability of report development activities.
7. Vendor & CRO Coordination
Manage distribution of finalized reports to:
CROs
Business Partners
External Stakeholders
Coordinate feedback and version control processes.
Ensure vendor compliance with reporting requirements.
8. Metrics & Compliance Monitoring
Generate and analyze:
Key Performance Indicators (KPIs)
Key Compliance Indicators (KCIs)
Submission Timeliness Metrics
Quality Metrics
Provide periodic reporting to leadership.
9. Literature Management Support
Support literature surveillance activities when required.
Assist in literature screening and documentation processes.
Ensure compliance with global literature monitoring procedures.
Key Performance Indicators (KPIs)
On-time PASR delivery
Quality review accuracy
Regulatory compliance rate
Audit and inspection readiness
Stakeholder satisfaction
KCI/KPI performance metrics
Documentation quality
Process efficiency improvements
Required Qualifications
Education
PharmD
M.Pharm
B.Pharm
Life Sciences
Biotechnology
Nursing
Medicine (MBBS preferred but not mandatory)
Required Experience
4–8 years of Pharmacovigilance experience.
Experience with:
Aggregate Safety Reporting
DSUR
PSUR/PBRER
PADER/PAER
Safety Documentation
Regulatory Compliance
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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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 :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
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Hilo | Honolulu |Tennessee :
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Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
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Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
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 :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
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 :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
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 :
Australia | Richmond Hill | Uxbridge | North York | Renfrew | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |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 :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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King Abdullah Economic City | Rabigh | Jeddah | Riyadh | Khulais | Najran |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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