Job Title: Assistant Manager – ICSR, PV
Req ID: 1359
Date Posted: September 19, 2025
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
CTC Range: INR 15,00,000 – 20,00,000
Educational Qualification
B.Pharm / M.Pharm / Pharm.D / MBBS / MD / BDS
Experience
Over 10 years of experience in ICSR management, XEVMPD management, and PSMF management
Organisational Overview
Lambda Therapeutics provides end-to-end pharmacovigilance solutions for generics, combination products, vaccines, and medical devices.
Expertise across all phases of drug safety monitoring ensures compliance with regulatory standards throughout a product’s lifecycle.
Key Highlights:
Global Expertise: Over 160 PV professionals, including physicians and specialists, supporting 265+ clinical trials across multiple therapeutic areas.
Robust Framework: Comprehensive pharmacovigilance systems ensuring regulatory compliance and patient safety.
Advanced Technology: Automated web-based PV solution compliant with international standards for accurate data handling.
Job Overview
Lead and manage ICSR, PSMF, and XEVMPD activities ensuring regulatory compliance and quality standards.
Oversee PV team performance, recruitment, and training, and provide expert pharmacovigilance guidance internally and to clients.
Key Responsibilities
Ensure compliance and quality of ICSR, PSMF, and XEVMPD according to client KPIs and Lambda quality manual.
Handle audits and regulatory inspections.
Maintain and update Lambda procedural documents in line with regulatory guidance.
Ensure all pharmacovigilance activities adhere to SOPs, regulations, and guidelines.
Recruit, appraise, and manage performance of aggregate report PV team staff.
Resolve review issues across functions and provide guidance to staff and clients.
Train PV staff on procedural documents and regulatory updates.
Required Competencies
Strong knowledge of ICSR, PSMF, and XEVMPD management.
Regulatory compliance and inspection readiness expertise.
Leadership and team management skills.
Effective communication and problem-solving abilities.
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Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Kerala :
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Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Swords |Dún Laoghaire :
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Dunboyne |Republic of Ireland :
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China | Quarry Bay |Hubei :
Wuhan |Liaoning :
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Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Leiden |North Yorkshire :
Harrogate |Oxfordshire :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Richmond Hill | Renfrew | Uxbridge | Australia | North York | Mississauga |Quebec :
Montreal |Chile :
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Croatia |Zagreb :
Zagreb |Bohemia :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
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Surabaya |Jakarta :
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Riyadh | Najran | Rabigh | King Abdullah Economic City | Khulais | Jeddah |Nišava District :
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