Discover the Perfect Career Opportunity for Safety Physicians in Bangalore – Safety Physician Jobs
Job Role: Safety Physician
Job Requisition ID: 269320
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.
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.