Patient Safety Physician or Medical Reviewer Pan India WFM
Patient Safety Physician or Medical Reviewer Pan India WFM
Posted on :
22-02-2025
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1 Vacancy
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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 selfmanage and selfmotivate.
Solution oriented and proactive behaviour
Ability to describe and present complex topics in an easytounderstand 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 riskbenefit 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.
NONMEASURABLE:
Selfdriven
Achievement oriented
Interface with other departments
Personal grooming and etiquette
Punctuality
Team player and process driven.
Employment Type
Full Time
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