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Patient Safety Physician or Medical Reviewer || Pan India || WFM

Remote: 
Full Remote
Contract: 
Full time
Work from: 
India

Offer summary

Qualifications:

MBBS Doctor with experience in safety writing and signal detection., Proficient in ICSR medical review/approval and MedDRA coding., Strong background in risk management and signal management activities., Excellent communication skills and ability to work under pressure..

Key responsabilities:

  • Draft PBRERs focusing on medical aspects and safety sections.
  • Develop Risk Management Plans as per regulatory requirements.
  • Analyze safety data for cumulative trends and signal assessment.
  • Collaborate with Therapeutic Area colleagues for signal conclusions and safety issues.

2COMS Consulting Pvt. Ltd. logo
2COMS Consulting Pvt. Ltd. http://www.2coms.com
10001 Employees
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Job description

Role Title Patient Safety Physician - SAR & SAR like 
Reporting To Patient Safety Physician – SAR & SAR like - Coordinator 
Essential educational Qualification and experience 
• MBBS Doctor with experience in safety writing and signal detection. 
• ICSR medical review/approval including MedDRA coding, listedness/expectedness,  
and seriousness assessment.  
• Risk management activities such as drafting, assessment, or implementation of RM  
activities. 
• Signal management activities such as drafting of qualitative and quantitative signal  
assessment reports. 
• Clinical practice experience in direct patient care.  
• Aggregate safety report drafting, review or assessment. 
Essential skills 
• Excellent presentation skills 
• Ability to act in an intercultural setting.  
• High affinity to process driven tasks and structured approaches. 
• Ability to self-manage and self-motivate.  
• Solution oriented and proactive behaviour 
• Ability to describe and present complex topics in an easy-to-understand way. 
• Excellent written and verbal communication including professional documentation skills. 
• Excellent ability to prioritize tasks, meet deadlines and work under changing conditions and high 
pressure. 
• Concern for timely completion of training activities and training documentation  
• Team Player 
• Knowledge of Clinical research and Pharmacovigilance processes 
Operational Responsibilities 
• Draft PBRERs with focus on medical aspects of the products and safety sections.  
Also, collecting and analysing various safety trends for the product. 
• Draft Risk Management Plans as per Regulatory requirement. Focus on the identification of risk and 
the categorization.  
• Determine adequate routine and additional risk minimization measures. 
• Draft medical safety response for queries received from various Health Authorities.  
 








 





 
This could require analysis of source data as per the query received. 
• Assist in identification, analysing and concluding safety data for any cumulative trends. 
• Searching and analysing published scientific literature for resolution of queries 
• Good knowledge of regulations in pharmacovigilance to assess the risk-benefit of a product and 
identify any gaps in the aggregate documents. 
• Provide medical input for analysis of Periodic Safety Update Reports, Expert Statements, Risk 
Management Plans, and other aggregate reports where appropriate, draft components of these reports. 
• Develop and maintain complete awareness of current regulations/alerts around aggregate reports, 
safety issues of products and RMPs. 
• Evaluation of the safety profile of products from multiple therapeutic areas 
• Conducting literature search for the signals to collect information on the possible mechanism of the 
occurrence of the AE. 
• Evaluation of case data for signal assessment, includes trend analysis.  
• Identify the various inputs required for drafting a signal report and participate in discussions for the 
meetings with Client. 
• Drafting signal assessment reports for AE across various therapeutic areas following a thorough 
review of the various sources of safety information 
• Collaboration with Therapeutic Head for conclusion of signals and any product safety issues 
• Interact with Therapeutic Area colleagues for better understanding, learning, and 
development. 
MEASURABLE: 
• 100% compliance for timely completion of all client and Cognizant required trainings. 
• 100% compliance for adherence to work allocation plan including case closure based upon agreed 
timelines (TAT) and applicable quality benchmark as per SOW. 
NON-MEASURABLE: 
• Self-driven 
• Achievement oriented 
• Interface with other departments 
• Personal grooming and etiquette 
• Punctuality 
• Team player and process driven. 

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Adaptability
  • Teamwork
  • Self-Motivation
  • Problem Solving
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