Officer – ICSR (Individual Case Safety Reports)
Company: Lambda Therapeutic Research Ltd.
Location: Ahmedabad, India
Employment Type: Full-Time
CTC Range: ₹3,00,000 – ₹5,00,000 per annum
About Lambda Therapeutic Research
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India, with strategic operations in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland). We provide comprehensive end-to-end clinical research services to pharmaceutical, biotech, and generic innovators worldwide, ensuring the development of safe and effective therapies.
Role Overview
We are seeking an Officer – ICSR to join our Pharmacovigilance (PV) team. The successful candidate will be responsible for pharmacovigilance case processing, including data entry, drug coding, MedDRA coding, causality assessment, and narrative writing. This role ensures compliance with global regulatory guidelines, contributes to SOP development, and supports the team in maintaining high-quality safety reporting standards.
Key Responsibilities
Perform ICSR case processing, including duplicate search, validation, drug coding, MedDRA coding, listedness, causality assessment, expediting assessment, and narrative writing in compliance with SOPs, WIs, and regulatory guidelines.
Prepare, review, and revise SOPs, Work Instructions, templates, guides, and training materials for PV activities.
Communicate urgent safety issues promptly to the Line Manager and QPPV.
Maintain accurate records of internal and external communications and ensure adherence to quality standards, timelines, and regulatory compliance.
Deliver training sessions for new joiners and team members, providing guidance and mentorship as needed.
Collaborate with the ICSR Team Leader to escalate issues beyond the normal scope and support the Group Leader in achieving 100% regulatory compliance for timely case processing.
Provide pharmacovigilance advice to clients and colleagues as required.
Stay updated on regulatory intelligence, implementing changes to ensure alignment with global PV requirements.
Assist in developing and implementing SOPs for Lambda’s Pharmacovigilance Department and clients.
Communicate with clients and regulatory agencies as needed.
Perform any other tasks assigned by the Line Manager to meet business objectives.
Required Qualifications
Education: Bachelor’s degree in Life Sciences, Pharmacy, or related field
Experience: Fresher candidates are encouraged to apply. Prior exposure to pharmacovigilance internships or academic projects is a plus.
Why Join Lambda Therapeutic Research
Gain hands-on experience in global pharmacovigilance operations and regulatory compliance.
Work in a dynamic, growth-oriented environment with opportunities for skill development and career progression.
Collaborate with experienced PV professionals and multidisciplinary teams across international locations.
Competitive salary package with opportunities to learn and advance in pharmacovigilance and clinical research.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
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 :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Budapest |BULGARIA :
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 :
Ballydine |Cork :
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Swords |Republic of China :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
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Wuhan |Capital of Netherland :
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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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Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
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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 :
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Saitama | Japan |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Bangkok |Israel :
Netanya | Kfar Saba | Yavne | Tel Aviv | Be'Er Sheva |Remote :
McFarland | Green Way | Springville | Nairobi | Remote - South America (Latin Americal) | French | Melbourne | Remote, USA | Zaragoza | Medan | Lenexa | Switzerland | Remote - Africa | Bountiful | Remote | Castlebar | Leinster | Bishop | Lousiana | Thailand | Regulatory Labeling Manager (NA and LATAM Only) | Hungary | Texas | Riga | Faridabad | Remote - Europe | Belgium | Tulsa | Minnesota | Ireland | Remote - Middle East | Hammond | Manipal | Slovakia | Victoria | Blue Bell | Xzagreb |Republic of Colombia :
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Brentwood |Bucharest :
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Ciudad de México | New Mexico |Dubai :
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Rabigh | Jeddah | King Abdullah Economic City | Khulais | Najran | Riyadh |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 :
Sarajevo |Singapore :
Singapore |Sofia City :
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