Senior Associate – Clinical Safety & Pharmacovigilance (ICSR Submission)
Department: Pharmacovigilance / Drug Safety
Location: Noida
Employment Type: Full-Time
Experience Required: 3–5 Years
Job Summary
The Senior Associate – Clinical Safety & Pharmacovigilance is responsible for preparation, quality review, and timely submission of Individual Case Safety Reports (ICSRs) to regulatory authorities, partners, and clients. The role ensures compliance with global pharmacovigilance regulations and supports patient safety through accurate and timely safety reporting.
Key Responsibilities
Prepare and submit expedited and non-expedited ICSRs to global health authorities and partners.
Ensure compliance with FDA, EMA, MHRA, PMDA, Health Canada, and other regulatory requirements.
Perform quality checks on case narratives, MedDRA coding, case data, and submission documentation.
Generate and transmit E2B(R2/R3) electronic reports through safety databases.
Monitor regulatory reporting timelines for serious, unexpected, and reportable adverse events.
Track acknowledgment receipts, submission status, and reconciliation activities.
Coordinate with case processing, medical review, QA, and regulatory teams.
Maintain submission records, audit trails, and inspection documentation.
Support SOP improvements and process enhancement initiatives.
Required Qualifications
Bachelor’s/Master’s degree in Pharmacy.
4–5 years of experience in Pharmacovigilance or Drug Safety.
Strong knowledge of ICSR lifecycle and regulatory reporting.
Experience with Oracle Argus Safety, ArisGlobal LifeSphere, or similar systems.
Required Skills
Knowledge of MedDRA and WHO Drug coding.
Understanding of E2B(R2/R3) standards.
Strong attention to detail and compliance mindset.
Excellent communication and documentation skills.
Advanced MS Excel and Word skills.
Preferred Experience
Gateway submission experience.
Knowledge of ICH E2A, E2B, E2D, GVP modules.
Experience with PV reconciliation and compliance metrics.
Estimated Salary Package (India)
₹8 – ₹14 LPA
(Depending on Argus expertise, submission experience, and organization)
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Bhubaneswar | Rourkela |Chhattisgarh :
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Delhi | Gangtok | New Delhi | PAN-India |Assam :
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Goa | Panaji | Verna |Bihar :
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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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
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Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
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Lake Charles | Shreveport |Nevada :
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Tuscaloosa |D.C :
Washington |Delaware :
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Germany | GErmany |Lower Saxony :
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Saarbrucken |Switzerland :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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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 :
Richmond Hill | Uxbridge | North York | Renfrew | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |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 :
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Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
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Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Be'Er Sheva | Netanya | Tel Aviv | Kfar Saba | Yavne |Remote :
Remote - South America (Latin Americal) | Minnesota | Ireland | Tulsa | Remote - Europe | Springville | McFarland | Hungary | Zaragoza | French | Melbourne | Lousiana | Hammond | Slovakia | Manipal | Belgium | Leinster | Perth | Green Way | Remote - Africa | Riga | Nairobi | Castlebar | Blue Bell | Xzagreb | Faridabad | Milwaukee | Medan | Texas | Bountiful | Thailand | Remote - Middle East | Bishop | Victoria | Lenexa | Regulatory Labeling Manager (NA and LATAM Only) | Switzerland |Republic of Colombia :
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New Mexico | Ciudad de México |Dubai :
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Jeddah | Riyadh | Rabigh | Khulais | Najran | King Abdullah Economic City |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 :
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