Icsr - Quality Reviewer

Lambda Therapeutics Limited

0-1 years

Not Disclosed

Ahmedabad

Openings: 12 Posted: May 7, 2024

Job Description

Job Type: Full Time Education: B. Pharm M. Pharm Pharm D. BDS MDS Other Life Science Graduate (B. Sc., M. Sc. etc) Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding,

Position: ICSR Quality Reviewer
Location: Ahmedabad
Experience: 0-1 year

Summary:

Enthusiastic and detail-oriented ICSR Quality Reviewer with 0-1 year of experience in pharmacovigilance. Dedicated to ensuring the accuracy and compliance of Individual Case Safety Reports (ICSRs) with regulatory requirements and company standards. Seeking to leverage skills in quality assurance and pharmacovigilance to contribute to the safety monitoring of pharmaceutical products.

Key Responsibilities:

Conducting quality reviews of Individual Case Safety Reports (ICSRs) to ensure accuracy, completeness, and compliance with regulatory requirements.
Identifying and documenting discrepancies or deficiencies in ICSR documentation and communicating findings to relevant stakeholders.
Collaborating with pharmacovigilance teams to address review findings and implement corrective actions as needed.
Participating in training programs to enhance understanding of pharmacovigilance regulations and quality review processes.
Assisting in the development and implementation of standard operating procedures (SOPs) related to ICSR quality review.
Contributing to continuous improvement initiatives to enhance the efficiency and effectiveness of ICSR quality review processes.

Requirements:

Bachelor's degree in life sciences or related field.
0-1 year of experience in pharmacovigilance or related field.
Knowledge of pharmacovigilance regulations and guidelines (e.g., ICH, FDA, EMA).
Strong attention to detail and ability to identify discrepancies in clinical data.
Excellent communication skills and ability to work effectively in a team environment.
Proficiency in Microsoft Office Suite and electronic document management systems.

Preferred Qualifications:

Certification in pharmacovigilance (e.g., RAPS RAC, DIA PV Program).
Experience with safety databases (e.g., ARISg, Argus).
Familiarity with adverse event reporting requirements for pharmaceutical products.
Understanding of medical terminology and pharmacology principles.