Manager - Safety Clinical R&D - Mumbai

17 hours ago

Mumbai, Maharashtra, India Cipla Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Job description

Title: Team Member/Manager Safety Clinical R&D

Job Location-Vikhroli, Mumbai

Prepare clinical development plan to ensure conduct of clinical studies as per regulatory requirements

Prepare strategy for the molecule about the design, sample size depending upon the market for conduct of the study, and present the same in cross-functional meetings

Prepare synopsis/ protocol of the study as per agreed upon strategy

Review safety sections of protocols received from vendors or prepared in-house, and provide medical inputs

Ensure the compliance of protocols for ICH-GCP and regulatory guidelines by reviewing them from a scientific perspective

Assess seriousness and criticality of safety issues to ensure safety of study participants

Resolve safety issues which arise from various study sites by co-ordinating with the concerned safety personnel/ investigator

Visit the various study sites for monitoring safety of study participants

Review the case record forms for discrepancies affecting the safety of the study participants

Review safety reports for regulatory submission

Review and analysis of study results to decide upon further action required

Visit the study sites for monitoring the study conduct as per protocol requirement

Prepare impact documents of study results

Provide inputs about the way forward for the molecule by analysing the study results

Review the clinical study report for safety and efficacy aspect as per ICH-GCP and other regulatory requirement

Resolve regulatory safety queries with medical rationale and therapeutic justification to ensure regulatory compliance

Provide reply to ethics committee and institutional review board queries regarding safety issues

Communicate with the regulatory officials regarding safety queries

Educational qualifications:

MBBS, Desirable: MD in Pharmacology

Relevant experience:

For MBBS, 3-4 years experience in clinical trials, pharmacovigilance or BA/BE studies

For MD, 1-2 years experience in clinical trials, pharmacovigilance or BA/BE studies

GCP awareness, sound medical knowledge, pharmacovigilance knowledge, communication skills and problem solving skills

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