Job Description

Team Leader - Medical Reviewer



Essential educational Qualification and experience

• MBBS Doctor with experience in safety writing and signal detection.

• ICSR medical review/approval including MedDRA coding, listed ness/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 behavior

• 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 analyzing 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, analyzing 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

Employee Status : Full Time Employee Shift : Day Job Travel : No Job Posting : Nov 15 2023
About Cognizant Cognizant (Nasdaq-100: CTSH) is one of the world\'s leading professional services companies, transforming clients\' business, operating and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant is ranked 185 on the Fortune 500 and is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com or follow us @Cognizant.