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Discover the Perfect Career Opportunity for Safety Physicians in Bangalore

Discover the Perfect Career Opportunity for Safety Physicians in Bangalore – Safety Physician Jobs

Job Role: Safety Physician

Job Requisition ID: 269320

Location: Bangalore

Career Level: D – Professional (4-9 years)

Working time model: full-time

Purpose of the Role

  • To perform the medical assessment of individual case safety reports (ICSR) in the organization’s safety database system.
  • Work in close collaboration with the involved stakeholders to ensure that each case is assessed in a proper way to ensure patient safety.
  • Work with the vendor performing the case management and/or medical assessment of ICSR on behalf of the organization to ensure the medical quality of the ICSR.
  • Interface with medical safety teams on active pharmacovigilance activities on products in clinical development and post-marketing.

Key Tasks & Responsibilities : Safety Physician Jobs

  • Medical review and approval of ICSR clinical trial cases by performing a thorough medical evaluation of serious and non-serious cases, authoring and/or reviewing the PV comment.
  • Contribution to quality KPI compilation while assessing the quality of medical assessment of cases reviewed and approved by vendors.
  • Ensure timely completion of tasks by daily monitoring of workflows.
  • Ensure close interaction with Medical Safety if an “Index-case” was identified.
  • Ensure issuing of proper medical queries to obtain follow-up information for the ICSR.
  • Provide operational expertise in case processing and medical assessment activities.
  • Contribute to regulatory inspections and audits and support the development of CAPA plans as needed.
  • Maintenance & data cleaning of reference tools and documents relevant to medical review activities.
  • Participate in internal and external training programs, meetings, and conferences to continually improve and build a knowledge base of product safety and risk management.
  • Contribute to the auto-labelling activity by reviewing and curating the data sheets.
  • Support MedDRA activities for cross-functional teams.

Education Requirements

Physician with MBBS/MD degree including relevant clinical experience.

Professional Skills & Experience

  • Minimum 4 years of professional experience in the pharmaceutical or biotech industry with at least 4 years in patient safety/pharmacovigilance.
  • Minimum of 2 years working in a hospital or private practice prior to joining the pharmaceutical industry.
  • Expert knowledge of international regulatory safety reporting requirements, including EMA/FDA/ICH guidance related to pharmacovigilance (e.g. E2B) and Good Pharmacovigilance Practices, as well as working knowledge of the Code of Federal Regulations regarding drug safety.
  • Expert in Medical Coding (e.g. MedDRA).
  • Good understanding of drug development and life-cycle management.

Personal Skills & Competencies : Safety Physician Jobs

  • Ability to work in intense, fast-paced, matrixed, multinational work environments.
  • Strong communication skills (oral, written, and listening).
  • Ability to effectively communicate with employees, colleagues, and global counterparts.
  • Positive motivator through demonstration.
  • Strong intercultural skills (developed from practical experience).
  • Strong team-working skills – working across cultural and functional boundaries, and participating in ‘virtual teams’.
  • Good problem-solving and decision-making ability.
  • Good organizational skills, ability to prioritize work and adapt rapidly to changing priorities.
  • Ability to manage multiple situations/issues under time pressure.
  • Effective presentation and training skills.
  • Ability to present and critically discuss safety data in both internal and external discussions.
  • Ability to evaluate, interpret and synthesize scientific data (analytical thinking).
  • Team player with the ability to function in a cross-functional environment.
  • Self–motivated, able to prioritize and plan effectively, and independently with minimal supervision.
  • Ability to navigate in databases and pull information correctly.
  • Good organizational skills and attention to detail.

Click here to Apply

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