Officer

Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries.

• Perform

  quality review of processed ICSRs

  , ensuring compliance with SOPs, WIs, regulatory guidelines, and timelines.


• Verify

  duplicate search, data entry, drug coding, MedDRA coding, listedness, causality assessment, expediting assessment

  , and narrative quality.


• Ensure cases meet

  regulatory reporting standards

  and are ready for submission.


• Review and provide feedback on

  SOPs, WIs, templates, guides, and training documents

  .


• Communicate

  critical quality issues

  promptly to Line Manager and QPPV.Maintain professional communication standards and accurate documentation of review findings.


• Ensure adherence to

  quality, consistency, and compliance

  with global PV requirements.


• Deliver

  training and guidance

  to case processors and new joiners on quality standards.


• Collaborate with Team Leaders to

  escalate quality concerns

  and support resolution.


• Support Group Leader in achieving

  100% regulatory compliance

  through timely and accurate reviews.


• Provide

  pharmacovigilance quality advice

  to clients and colleagues as needed.Mentor and assist less experienced team members to improve quality performance.


• Stay updated on

  regulatory changes

  and implement quality improvements accordingly.


• Assist in developing and revising

  quality-related SOPs and processes

  for Lambda s PV Department and clients.


• Communicate with clients and/or regulatory agencies regarding quality matters when required.Perform any other tasks assigned by Line Manager to meet business needs.

2-4 years

Life Sciences, Pharmacy, Nursing, or related field