Medical Safety Expert

4 days ago

Hyderabad, Telangana, India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Job Description Summary

-Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs. Participates in the resolution of any legal liability and complying with governmental regulations. Provides and contributes trending and safety signal detection and risk management assessment for the products' life cycle. Provides safety support to the clinical development teams.

Job Description

Major accountabilities:
  • Provides support according to the needs for delivery activities, i.e. co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries.
  • Assist in monitoring the safety profile of products including with activities such as literature review, medical review/evaluation of individual cases or signal detection.
  • Perform literature review -Provide support for the preparation of ad hoc Health Authority queries for TAs, also in particular for short term notice requests.
  • Perform follow up activities on Health Authority Assessment Reports.
  • Assist in providing safety input to Regulatory Affairs and clinical documents.
  • Support maintenance and management of local deviations -Assist in evaluating and writing other safety deliverables as assigned -Provide support as needed for new indication submission (regulatory document safety input).
  • Prepare responses to internal safety requests and contribution to responses to external safety queries.
  • Act as Subject Matter Expert (SME) for Medical Operations/ Medical Function -Lead the training and mentoring of junior team members/colleagues -Distribution of marketing samples (where applicable)
Key performance indicators:
  • Timeliness and quality of safety analyses, interpretations, and presentations -Compliance with internal and external regulations and procedures -Compliance, consistency and quality of safety deliverables
Minimum Requirements:
Work Experience:
  • People Challenges.
  • Managing Crises.
  • Functional Breadth.
  • Collaborating across boundaries.
  • Operations Management and Execution.
  • Project Management.
Skills:
  • Clinical Research.
  • Clinical Trials.
  • Functional Teams.
  • Literature Review.
  • Medical Records.
  • Process Safety.
  • Regulatory Compliance.
  • Safety Science.
Languages :
  • English.

Skills Desired

Clinical Research, Clinical Trials, Functional Teams, Literature Review, Medical Records, Process Safety, Regulatory Compliance, Safety Science

  • Medical Safety Processes and Projects Manager

    2 weeks ago

    Hyderabad, Telangana, India Novartis Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Job Description SummaryThis role combines responsibilities in Medical Safety Operations (addressing pharmacovigilance (PV) needs) with Project Management activities. Reporting to the Head Medical Safety (MS) Processes & Projects, the MS Processes and Projects (MS P&P) Manager is responsible for planning of deliverables associated with MS owned processes and...

  • Medical Safety Processes and Projects Manager

    2 weeks ago

    Hyderabad, Telangana, India Novartis Full time ₹ 8,00,000 - ₹ 24,00,000 per year

    SummaryThis role combines responsibilities in Medical Safety Operations (addressing pharmacovigilance (PV) needs) with Project Management activities. Reporting to the Head Medical Safety (MS) Processes & Projects, the MS Processes and Projects (MS P&P) Manager is responsible for planning of deliverables associated with MS owned processes and other key...

  • Medical Coding Subject Matter Expert

    3 days ago

    Hyderabad, Telangana, India Ascent Business Solutions Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    We're Hiring Medical Coding – Subject Matter ExpertAt Ascent Health, we are expanding our team and welcoming skilled professionals who are passionate about excellence in medical coding. Role: Medical Coding – Subject Matter Expert Specialties: E/M OP (Outpatient ) Location: Hyderabad (Uppal) Work Mode: 5 Days | Work From Office Experience: 4+ years in...

  • Global Medical Maintenance Expert

    7 days ago

    Hyderabad, Telangana, India Opella Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job title: Global Medical Maintenance ExpertLocation: HyderabadOpella is the self-care challenger with the purest andthird-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.Our mission: to bring health in people's hands bymaking self-care as simple as it should befor over half a billion consumers...

  • Global Medical Maintenance Expert

    1 week ago

    Hyderabad, Telangana, India Opella Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Job title: Global Medical Maintenance ExpertLocation: HyderabadOpella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.​Our mission: to bring health in people's hands by making self-care as simple as it should be for over half a billion consumers...

  • Medical Monitoring

    1 week ago

    Hyderabad, Telangana, India Dr Reddys Laboratories Full time ₹ 1,00,000 - ₹ 1,50,000 per year

    Group Lead - Medical Monitoring & Safety Company Description Dr. Reddy's Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can't Wait. We...

  • Medical Monitor

    7 days ago

    Hyderabad, Telangana, India Shilpa Medicare Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Role & responsibilitiesProvide comprehensive medical and scientific expertise and oversight for clinical trials, ensuring study integrity and participant safety.Review and contribute medical input to study protocols, ensuring clinical feasibility, scientific rigor, and compliance with regulatory requirements and guidelines.Ensure strict adherence to clinical...

  • Duty Medical Officer

    2 weeks ago

    Hyderabad, Telangana, India Navjeevan hospital Full time ₹ 18,00,000 - ₹ 36,00,000 per year

    Patient care: Perform initial assessments, diagnose conditions, administer treatments, and provide ongoing care for inpatients.Emergency management: Respond to and manage medical emergencies, stabilizing patients in critical situations.Coordination: Act as the main point of contact during shifts, collaborating with nurses, specialists, and other medical...

  • Duty Medical Officer

    1 week ago

    Hyderabad, Telangana, India Yashoda Super Specialty Hospital Full time ₹ 5,00,000 - ₹ 8,00,000 per year

    Role & responsibilitiesWe are urgently hiring for the following positions at Yashoda hospital, Hyderabad. Duty Medical Officer - MBBS - 2+ yrs experience. Senior Medical Officer - MBBS- 5-7 yrs experience in (Oncology & surgical Oncology ). Community Medical Officer -MBBS- 3-5 yrs experience in relevant role. Qualification :MBBS- REGISTRATION MANDATORY...

  • Duty Medical Officer

    15 minutes ago

    Hyderabad, Telangana, India Yashoda Super Specialty Hospital Full time ₹ 2,00,000 - ₹ 8,00,000 per year

    Role & responsibilitiesWe are urgently hiring for the following positions at Yashoda hospital, Hyderabad. 1. Duty Medical Officer - MBBS - 2+ yrs experience.2. Senior Medical Officer - MBBS- 5-7 yrs experience in (Oncology & surgical Oncology ).3. Community Medical Officer -MBBS- 3-5 yrs experience in relevant role. Qualification :MBBS- REGISTRATION...