Manager - Safety Clinical R&D - Mumbai
21 hours ago
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
-
Clinical Science Lead
2 weeks ago
Mumbai, Maharashtra, India Maxis Clinical Sciences Full time ₹ 1,04,000 - ₹ 1,30,878 per yearHiring for Clinical Science Lead - Medical Monitoring for a leading Pharma clientMumbaiTASKS AND RESPONSIBILITIESLead the clinical research medical science related activities such as preparation of synopsis, protocol, Clinical Study Report (CSR) and present the proposals in subjects expert committee (SEC) regulatory meetingCollaborate with clinicians, KOL to...
-
R&D Manager
3 days ago
Mumbai, Maharashtra, India Siemens Full time ₹ 20,00,000 - ₹ 25,00,000 per yearJob Description: As a candidate with over 20 years of experience in design and development of AIS and GIS High voltage switchgear, your role at Siemens Energy will involve being an expert in developing different mechanisms for Circuit Breaker and GIS. You will be responsible for performing finite element analysis, including static structural, linear and...
-
Head R&D
1 week ago
Mumbai, Maharashtra, India Michael Page Full time ₹ 20,00,000 - ₹ 25,00,000 per yearCandidates with MTech/PhD in Polymer/Material Science or Chemical EngineeringCandidates who have led R&D for sun control/architectural/paint protection filmsAbout Our ClientThe hiring organization is a well-established and respected name in the Poly film manufacturing industry. As a company, it is known for its technical expertise and commitment to...
-
Research associated
17 hours ago
Mumbai, Maharashtra, India Macleods Pharma. Limited. (R & D Centre), Mumbai Full time ₹ 6,00,000 - ₹ 8,00,000 per yearCompany DescriptionMacleods Pharma. Limited. (R & D Centre), Mumbai, is a prominent biotechnology company specializing in pharmaceutical research and development. Headquartered in Maharashtra, India, the organization is known for addressing complex medical challenges through innovative solutions. With a strong commitment to advancing healthcare, Macleods...
-
Clinical Science Lead
6 days ago
Mumbai, Maharashtra, India Maxis Clinical Sciences Full time ₹ 20,00,000 - ₹ 25,00,000 per yearCollaborate with clinicians, KOL to get the feedback and inputs on clinical trial design, comparator and endpoints of the study to finalize synopsis.Lead the clinical research medical science related activities such as preparation of synopsis, protocol, Clinical Study Report (CSR) and present the proposals in subjects expert committee (SEC) regulatory...
-
Head of Quality Assurance, R
3 days ago
Mumbai, Maharashtra, India Umedica Laboratories Private Limited Full time ₹ 5,00,000 - ₹ 15,00,000 per yearCompany DescriptionUMEDICA is part of the Amoli Group of Companies, specializing in the manufacture and export of a diverse range of pharmaceutical formulations including injectables, tablets, and capsules. Based in Vapi, Gujarat, our facility is approved by WHO GMP, US FDA, EU, Health Canada, and TGA among others. UMEDICA operates globally in over 85...
-
R&D Analyst
1 week ago
Mumbai, Maharashtra, India Solenis Full time ₹ 6,00,000 - ₹ 18,00,000 per yearDepartment: Research & Development – Food & BeverageLocation: MumbaiPosition reporting to: Global R&D - ManagerABOUT SOLENISSolenis is a leading global producer of specialty chemicals focused on partnering with water-intensive operations to solve complex water treatment, process improvement and hygiene challenges with advanced chemical and equipment...
-
R&D Chemist
6 days ago
Navi Mumbai, Maharashtra, India CIEL HR Full time ₹ 9,00,000 - ₹ 12,00,000 per yearPosition Summary:We are seeking a motivated and detail-oriented R&D Chemist to join our Research and Development team. The successful candidate will be responsible for developing and optimizing chemical formulations, conducting experiments and contributing to the innovation of new products. This position requires strong foundation in chemistry, analytical...
-
Clinical Quality Assurance Compliance
2 weeks ago
Mumbai, Maharashtra, India Maxis Clinical Sciences Full time ₹ 20,00,000 - ₹ 25,00,000 per yearJob Title:Clinical Quality Assurance Compliance & trainingExperience: 5 plus yearsLocation:MumbaiType:Full-timeExperience Level:[Senior] Manager/Senior ManagerDepartment:Clinical Research DepartmentPurpose of this Role:This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable...
-
Manager Clinical Quality Compliance andTraining
2 weeks ago
Mumbai, Maharashtra, India Maxis Clinical Sciences Full time ₹ 12,00,000 - ₹ 36,00,000 per yearPosition Title: Sr. Manager/ Manager Clinical Quality Compliance and TrainingYOUR TASKS AND RESPONSIBILITIES: This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective.This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical...