Senior Medical Safety Expert

3 days ago

Kota, Rajasthan, India beBeeClinical Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

We are seeking an experienced Team Lead/Manager/Senior Medical Advisor to join our organization. This individual will be responsible for leading medical review teams, ensuring compliance with regulatory requirements, and providing excellent client communications.

Key Responsibilities:

  • Lead as a medical monitor/expert in all aspects of clinical and post-marketing drug safety
  • Medical Monitoring experience is essential, and the ability to effectively communicate with clients, attend investigator meetings, and provide support to sites regarding protocol or possible drug interactions is critical.
  • Review and provide feedback on study protocols as needed.
  • Deliver therapeutic area training for all case processing team members.
  • Maintain 24/7 availability to address client queries or protocol deviations that may result in potential harm to patients.
  • Drafting medical monitoring plans (MMP) and ensuring compliance.
  • Reviewing adverse events (AEs) reported by study sites, assessing their severity, and determining appropriate actions.
  • Make assessments on SUSAR reportability.
  • Perform the review and interpret clinical data, ensure protocol compliance, and draft monthly reports for clients (with presentation at periodic meetings if required).
  • Develop and update current training materials in line with GCP and GVP requirements for medical review of all cases.

Post-Marketing (Pharmacovigilance):

  • Support in maintenance of medical platform including SOPs, manual, and documents.
  • Lead and support the medical reviewers.
  • Interaction with the clients' medical team and clinical team.
  • Act as the main responsible person at PLG for clients' concerns and escalation.
  • Medical review of the ICSRs (e.g., Spontaneous, literature).
  • Support in causality, medical assessment, benefit-risk evaluation of the medicinal product.
  • Mentor junior medical reviewers and perform additional review of cases to ensure competency.
  • Provide feedback and ongoing workshops to develop the medical reviewers.
  • Participate in audits and inspections as required.
  • Educate other team members.

Required Qualifications:

  • MBBS, or MD (Doctor of Medicine)
  • Experience in leading medical review teams
  • Client communications
  • Safety Database experience
  • Minimum 10 years experience working for service providers or pharmaceutical companies
  • At least 5-7 years of experience as a Medical Monitor or clinical phase

Preferred Skills:

  • Microsoft package
  • Pharmaceutical background – strong understanding of GVP, GCP, FDA, and regulatory requirements related to drug safety.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.
  • Working knowledge of EDC systems
  • Good Medical knowledge and Pharmacology understanding

  • Senior medical safety advisor

    2 weeks ago

    Kota, Rajasthan, India IQVIA Full time

    Role: Senior Medical Safety AdvisorWork Experience: 5+ Years.Clinical Experience: 3+ Years.Pharmacovigilance/PV Experience: 2+ YearsWork location: PAN IndiaWork Mode: Home BasedMust Have Skills: Pharmacovigilance, ICSR.Job OverviewThe objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part...

  • Senior Medicinal Science Expert

    1 week ago

    Kota, Rajasthan, India beBeeMedical Full time ₹ 1,20,00,000 - ₹ 2,00,00,000

    Job Title: Senior Medical Safety AdvisorRole Overview:To provide medical expertise in the evaluation of safety data from various sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of a product's safety profile.Key Responsibilities:Conduct thorough...

  • Medical Devices Quality Management Expert

    1 week ago

    Kota, Rajasthan, India beBeeEngineering Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Senior Medical Devices Engineer OpportunityWe are seeking a highly skilled Senior Medical Devices Engineer with extensive experience in quality management, regulatory affairs, and risk management to lead our medical devices team. This is an exciting opportunity for a professional to develop and implement quality management systems, ensuring compliance with...

  • Expert Medical Coding Specialist

    1 week ago

    Kota, Rajasthan, India beBeeCoder Full time ₹ 9,00,000 - ₹ 12,00,000

    Senior Medical CoderAs a Senior Medical Coder, you will be responsible for reviewing medical records and assigning accurate codes to ensure proper reimbursement.Responsibilities:Review medical records to assign ICD-10-CM & PCS diagnoses and procedure codes correctly and completely.Have extensive knowledge of medical terminology and coding rules and...

  • AI Expert in Medical Sciences

    2 weeks ago

    Kota, Rajasthan, India beBeeResearch Full time US$ 1,80,000 - US$ 2,50,000

    PhD in Medical Sciences ResearcherAs a highly skilled PhD-level expert in Medical Sciences, you will play a pivotal role in enhancing and refining AI systems used by top global organizations.Create, review, or annotate high-quality medical and scientific content and datasets to train or evaluate AI systems.Contribute to the development of AI models that...

  • Expert Medical Data Analyst

    2 days ago

    Kota, Rajasthan, India beBeeData Full time ₹ 15,00,000 - ₹ 21,00,000

    Medical Data Quality Assurance ExpertEnsure the accuracy and reliability of medical data analysis tools by performing thorough manual testing.Conduct comprehensive test plans to validate complex patient data processing, focusing on user experience, data accuracy, and workflow validation.Collaborate with engineers, product managers, and domain experts to...

  • Medical Professional

    4 days ago

    Kota, Rajasthan, India beBeeMedical Full time ₹ 75,00,000 - ₹ 1,50,00,000

    Job Title: Medical ProfessionalJob SummaryEvaluate the accuracy and safety of AI-generated medical content to ensure it meets high standards.Key responsibilities include reviewing summaries of medical conversations, assessing patient scenarios, and determining likely diagnoses/treatment plans.This role requires a medical doctor with an active license and...

  • Medical Care Specialist

    2 days ago

    Kota, Rajasthan, India beBeeCare Full time ₹ 10,00,000 - ₹ 20,00,000

    Medical Services Manager Job DescriptionOverview:We are seeking an experienced and skilled Medical Services Manager to oversee the delivery of high-quality clinical care services at our healthcare unit. This is a challenging role that requires strong leadership skills, a passion for patient safety, and a commitment to delivering excellent care.Job...

  • Medical Equipment Specialist

    1 week ago

    Kota, Rajasthan, India beBeeBiomedical Full time ₹ 90,00,000 - ₹ 1,20,00,000

    Job Title: Medical Equipment SpecialistJob Description:We are seeking a skilled Medical Equipment Specialist to maintain and repair medical devices, ensuring they meet safety and performance standards. This role involves performing routine maintenance tasks, troubleshooting equipment issues, and collaborating with clinical engineering teams.The ideal...

  • Senior Institutional Development Expert

    4 days ago

    Kota, Rajasthan, India beBeeDevelopment Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Job OpportunityProfessional Overview:As a Senior Institutional Development Expert, you will play a pivotal role in enhancing the capacity and effectiveness of Central and DRIP IAs.You will develop and finalize comprehensive annual training calendars for capacity-building programs, focusing on dam safety institutional strengthening.Coordinate and implement...