Current jobs related to Senior Medical Safety Advisor - Bengaluru, Karnataka - IQVIA

  • Senior Medical Advisor

    2 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Department - Medical AffairsAre you an experienced medical professional and passionate about Medical Affairs Does being part of a growing yet dynamic environment excite you Is you adept in implementing the medical affairs strategy in the country If yes then you may be the one we are looking for as Sr Medical Advisor for Novo Nordisk India Apply now The...

  • Senior medical biller/ senior medical coder

    2 weeks ago

    Bengaluru, Karnataka, India Orchestrate Medical Full time

    Job Title: Team Lead / Senior Medical Biller/ Senior Medical CoderLocation: Remote / BangaloreCompany: Dr New Med.com / Required: Minimum 7 yearsSpecialty Preferred: CardiologySoftware Expertise Preferred: Athena EHR & Next Gen HER is an added advantage. Job Summary:We are seeking a highly experienced and detail-oriented Medical Biller/Coder to join our...

  • Medical Safety Specialist

    1 week ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 12,00,000 - ₹ 18,00,000

    Medical Safety Specialist RoleWe are a technology-driven healthcare organization dedicated to safeguarding patient safety through rigorous medical evaluation and regulatory compliance. We offer accelerated growth opportunities for talent that's analytical, critical-thinking, and detail-oriented.As a Medical Safety Specialist, you will play a critical role in...

  • Senior Medical Biller/ Senior Medical Coder

    2 weeks ago

    Bengaluru, Karnataka, India Orchestrate Medical Full time

    Job Title: Team Lead / Senior Medical Biller/ Senior Medical CoderLocation: Remote / BangaloreCompany: DrNewMed.com /   https://www.orchestratemedical.com/Experience Required: Minimum 7 yearsSpecialty Preferred: CardiologySoftware Expertise Preferred: Athena EHR & NextGen HER is an added advantage. Job Summary:We are seeking a highly experienced and...

  • Senior Medical Biller/ Senior Medical Coder

    2 weeks ago

    Bengaluru, Karnataka, India Orchestrate Medical Full time

    Job Title: Team Lead / Senior Medical Biller/ Senior Medical Coder Location: Remote / Bangalore Company: DrNewMed.com /    Experience Required: Minimum 7 years Specialty Preferred: Cardiology Software Expertise Preferred: Athena EHR & NextGen HER is an added advantage. Job Summary: We are seeking a highly experienced and detail-oriented Medical...

  • Lead Medical Advisor

    2 weeks ago

    Bengaluru, Karnataka, India beBeeMedicalAdvisor Full time ₹ 5,00,000 - ₹ 8,00,000

    Lead Medical Advisor - Therapy Area ExpertWe are seeking a highly skilled Lead Medical Advisor to play a pivotal role in our organization. This individual will be responsible for leading the medical affairs strategy across various therapy areas, working closely with cross-functional teams to develop and execute plans that drive business growth.The ideal...

  • Medical Reviewer/Drug Safety Physician

    2 weeks ago

    Bengaluru, Karnataka, India Propharma Group Full time US$ 90,000 - US$ 1,20,000 per year

    The PV Drug Safety Physician should be able to perform medical review of all types of individual case safety reports (ICSRs) by writing an expert company pharmacovigilance comment. The PV Drug Safety Physician maintains distinctive quality and commitment as the operating philosophy in carrying out all processes., and continually seeks out ways to enhance...

  • Physician Medical Safety Specialist

    2 weeks ago

    Bengaluru, Karnataka, India beBeeMedicalReviewer Full time ₹ 13,51,897 - ₹ 16,22,273

    Medical Reviewer Job Description:As a medical reviewer, you will be responsible for the comprehensive review of individual case safety reports (ICSRs) and ensuring compliance with regulatory requirements.Perform medical review of ICSRs for accuracy, medical relevance, and consistency with source documents and safety database entries, in alignment with client...

  • Drug Safety Physician

    2 weeks ago

    Bengaluru, Karnataka, India beBeeMedSafety Full time ₹ 25,00,000 - ₹ 35,00,000

    Medical Reviewer - Drug Safety Physician Job SummaryThis role plays a critical part in protecting patient safety by conducting thorough medical evaluations and regulatory reporting.About the Position:As a Medical Reviewer, you will be responsible for reviewing individual case safety reports (ICSRs) to ensure accuracy and consistency with source documents and...

  • Aggregate Safety Reports Medical Content Specialist

    2 weeks ago

    Bengaluru, Karnataka, India beBeeWriter Full time ₹ 9,00,000 - ₹ 12,00,000

    Medical Writer RoleWe are seeking a highly skilled Medical Writer to author aggregate safety reports and join our Safety team.Responsibilities:Accountable for the entire life cycle of documents, ensuring quality, timeliness, and compliance with internal/client SOPs and regulations.Responsible for end-to-end authoring of complex deliverables – periodic...

Senior Medical Safety Advisor

2 weeks ago

Bengaluru, Karnataka, India IQVIA Full time ₹ 1,04,000 - ₹ 1,30,878 per year

Role Name - Sr Medical safety advisor

Education qualification - MBBS/MD.

Location - Home Based.

Work exp - Aggregate Report and Signal Mgt.

Job Overview

The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the products safety profile as well as other products within the same therapeutic area. Also, this position plays a greater role as a senior technical leader and participate in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts and Safety Surveillance Group and be responsible for surveillance activities for selected products.

Essential Functions


• Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary


• Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements


• Provide coding review of AEs, SAEs, SADRs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data


• Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported


• Perform medical safety review of the protocol, Investigative Brochure, and/or Case Report Forms (CRFs) for appropriate safety content and data capture, as applicable


• Provide aggregate reviews of safety information, including but not limited to clinical data, post marketing, literature review and observational studies to maintain oversight of a products safety profile (e.g: DSUR, RMP, PBRER, ad hoc regulatory reports etc)


• Ensure service delivery from productivity, compliance and quality perspective within regulatory /contracted timelines. Lead and participate in the initiatives taken for the same from team delivery perspective.


• Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing other safety team members in single case assessment.


• Ensure update of watch list, list of expectedness, labeling list/RSIs etc. for the assigned products and develop such additional capabilities within the team


• Lead, drive and participate in training activities, product transitions, audit preparation and knowledge exchange initiatives


• Review and sign off on the Project Safety Plan and Medical Monitoring Plan per medical safety scope agreed in contract, as applicable


• Attend project meetings, medical safety team meetings, and represent safety and clinical data review findings during client meetings, as applicable


• Act as Lead Safety Physician, or additional team support, and/or back up on assigned projects as applicable


• Provide medical escalation support for medical information and EU Qualified Persons for Pharmacovigilance projects, as applicable


• 24-hour medical support as required on assigned projects


• Maintain awareness of medical safety-regulatory industry developments


• Provide support and participate in signal detection efforts, e.g. strategy meetings etc. as applicable Qualifications


• Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education. Req


• Three (3 years) experience practicing clinical medicine after award of medical degree. Graduate, and/or Residency training can qualify for clinical practice experience Req.


• Two (2) years of pharma experience Pref


• Sound knowledge of Medicine


• In-depth knowledge of applicable global, regional, and local clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines


• Knowledge of Pharmacovigilance- ICSR and Aggregate reports


• In-depth knowledge of departmental standard operating procedures (SOPs)


• Skill in use of multiple safety databases


• Adequate Computer skills, especially Microsoft word, excel & PowerPoint


• Good communication skills- verbal and written


• Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients, and regulatory agency representatives


• Ability to establish and maintain effective working relationships with coworkers, managers, and clients


• A valid medical license, or equivalent, from the country or region in which he/she resides and works Preferred.