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Assistant Manager - Icsr, Pv

10 years
Not Disclosed
10 Oct. 7, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.