Job Title:  Assistant Manager - ICSR, PV

ORGANISATIONAL OVERVIEW

At Lambda Therapeutics, we provide end-to-end pharmacovigilance solutions tailored for a variety of products, including generics, combination products, vaccines, and medical devices. Our extensive experience encompasses all phases of drug safety monitoring, ensuring compliance with regulatory standards throughout the entire lifecycle of medicinal products.

Key Highlights of Our Pharmacovigilance Services:

• Global Expertise: With a dedicated team of over 160 professionals, including physicians and pharmacovigilance specialists, we have successfully supported more than 265 clinical trials across diverse therapeutic areas.
• Robust Framework: Our well-established pharmacovigilance framework guarantees thorough safety monitoring and adherence to regulatory requirements, empowering drug safety and enhancing patient well-being.
• Advanced Technology: We utilize an automated web-based pharmacovigilance solution compliant with international standards, which streamlines processes and ensures accuracy in data handling.

JOB DETAILS

• Responsible for ensuring compliance of ICSR, PSMF and xEVMPD as per client KPI and regulatory compliance.
• Responsible for ensuring quality of ICSR, PSMF and xEVMPD as per client Lambda quality manual and client KPI
• Responsible for handling audit and regulatory inspections
• Responsible for ensuring Lambda procedural documents are inline with regulatory guidance and updated in timely manner in case of revision of guidance.
• Responsible for ensuring pharmacovigilance activities within Lambda are carried out in accordance with all SOPs, relevant regulations and guidelines.
• Responsible for Selection and recruitment of relevant PV staff of aggregate report team
• Interact with staff at various levels and in various functional areas to resolve any issues that arise during reviews also responsible for staff appraisals and performance management of aggregate report team
• To ensure the provision of appropriate pharmacovigilance advice to clients and colleagues
• Responsible for ensuring all PV staff are trained on Lambda procedural documents and relevant regulatory guidance.

EXPERIENCE

> 10 years of Experience in ICSR Management, XEVMPD Management, PSMF Managment

EDUCATIONAL QUALIFICATION

B. Pharm, M. Pharm, Pharm D., MBBS, MD, BDS