Senior Associate – Clinical Safety & Pharmacovigilance (ICSR Submission)
Location: Noida
Employment Type: Full-Time
Experience Required: 3–5 Years (Job responsibilities indicate 4–5 years of relevant Pharmacovigilance experience preferred)
Salary Package
Expected CTC: ₹6 LPA – ₹10 LPA (Estimated market range for Noida based on experience, organization, and skill set. The original job description does not specify a salary.)
Department
Pharmacovigilance / Drug Safety
Job Summary
The Senior Associate – Clinical Safety & Pharmacovigilance (ICSR Submission) is responsible for preparing, reviewing, and submitting Individual Case Safety Reports (ICSRs) to global regulatory authorities, business partners, and clients in compliance with international pharmacovigilance regulations and company procedures. The role focuses on ensuring accurate, timely, and compliant safety reporting to support patient safety and regulatory requirements.
Key Responsibilities
Prepare and submit expedited and non-expedited Individual Case Safety Reports (ICSRs) to global health authorities, clients, and business partners.
Ensure submissions comply with regulatory requirements of FDA, EMA, MHRA, PMDA, Health Canada, and other global health authorities.
Perform quality control (QC) checks on case data, narratives, MedDRA coding, and submission documentation.
Generate and transmit E2B(R3) electronic safety reports using pharmacovigilance databases and reporting gateways.
Monitor regulatory submission timelines for serious, unexpected, and reportable adverse events.
Track submission acknowledgements, reconciliation activities, and case submission status.
Coordinate with case processing, medical review, quality assurance, and regulatory affairs teams to resolve submission-related issues.
Maintain accurate submission records, documentation, and audit trails.
Support regulatory inspections and internal audits by providing required submission documents.
Participate in process improvement initiatives, SOP reviews, and quality enhancement activities.
Required Qualifications
Bachelor's or Master's degree in Pharmacy or a related Life Sciences discipline.
4–5 years of experience in Pharmacovigilance, Drug Safety, or ICSR submission activities.
Strong understanding of global pharmacovigilance regulations and safety reporting requirements.
Hands-on experience with safety databases such as Oracle Argus Safety, ArisGlobal LifeSphere, or similar pharmacovigilance systems.
Required Skills
Strong knowledge of the ICSR lifecycle and global regulatory reporting timelines.
Familiarity with E2B(R2) and E2B(R3) submission standards.
Knowledge of MedDRA and WHO Drug coding.
High attention to detail with a strong focus on data quality.
Excellent organizational and time management skills.
Ability to manage multiple submissions within strict regulatory timelines.
Strong written and verbal communication skills.
Proficiency in Microsoft Office applications, especially Excel and Word.
Preferred Skills
Experience with gateway submissions and health authority portals.
Good understanding of ICH E2A, ICH E2B, ICH E2D, GVP Modules, and FDA safety reporting requirements.
Experience in reconciliation activities and submission troubleshooting.
Knowledge of pharmacovigilance compliance metrics and regulatory reporting.
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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Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
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 :
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 :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Concord | Lumberton | North Carolina |Michigan :
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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 :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
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 :
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Germany | GErmany |Lower Saxony :
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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 :
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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 :
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 :
Almaty |Republic of Thailand :
Bangkok |Israel :
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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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
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 :
Sarajevo |Singapore :
Singapore |Sofia City :
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Sweden |Taipei :
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