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Aggregate Report Writer PSUR & DSUR || WFH

Role overview

Summary

This role focuses on compiling and analyzing safety reports to ensure product safety and compliance. You will work closely with the Therapeutic Head and colleagues to identify safety signals and trends, contributing to the overall patient safety efforts within the organization.

Qualifications

  • Relevant educational background and experience in patient safety or related field.
  • Strong presentation and communication skills.
  • Effective intercultural work capabilities.
  • Commitment to timely completion of tasks and documentation.
  • Analytical and problem-solving skills.

Responsibilities

  • Compile PBRERs focusing on medical aspects and safety sections of products.
  • Analyze safety trends, including source data analysis based on queries.
  • Collaborate with the Therapeutic Head to identify signals and address product safety concerns.
  • Engage with Therapeutic Area colleagues for enhanced understanding and development.

Key facts

Hard skills

Other skills

  • Presentations
  • Communication
  • Analytical Skills
  • Problem Solving
  • Collaboration
  • Intercultural Competence
  • Self-Motivation
  • Goal-Oriented
  • Punctuality

About the company

2COMS Consulting Pvt. Ltd. logo

2COMS Consulting Pvt. Ltd.

  • Staffing & Recruiting
  • 10,001+
2COMS Consulting focuses on the #HumanSideOfThings – helping organizations become sustainable leaders by connecting them to the right talent. We are a Human Supply Chain management company with over 10,515+ employees, spread across seven locations. As an NSDC partner, we help more than 4000 professionals meet their career goals by connecting them with over 70 clients, daily. Our manpower solutions are customized and aligned with our clients’ requirements – financial management, continuous performance improvement, and integrated technology enablement. It is our continuous endeavours of the past 20 years that helped us strengthen our relationships with our partners and gain diversified experience spanning industries. For more information, visit the link below: https://www.2coms.com/

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Job description

SAR & SAR-like Patient Safety Physician


Job Description


  • Responsible for compiling PBRERs with a focus on medical aspects and safety sections of products, and analyzing safety trends, including source data analysis based on queries
  • Assisting in identifying, analyzing, and drawing conclusions from safety data for cumulative trends
  • Collaborating with Therapeutic Head to identify signals and address product safety concerns
  • Engaging with Therapeutic Area colleagues for enhanced understanding and development

Measurable Goals


  • Ensuring 100% compliance with timely completion of all client and Cognizant required trainings
  • Achieving 100% compliance with work allocation plan, including case closure based on agreed timelines and quality benchmarks

Non-Measurable Attributes


  • Self-motivated
  • Goal-oriented
  • Interdepartmental collaboration
  • Personal grooming and etiquette
  • Punctuality
  • Team player and process-oriented

Competencies


  • Proficient in delivering presentations
  • Effective at collaborating across different cultures
  • Strong preference for structured and process-driven tasks
  • Committed to completing training and documentation on time

Experience


  • Relevant educational background and experience in patient safety or related field

Required Skills


  • Strong presentation and communication skills
  • Effective intercultural work capabilities
  • Commitment to timely completion of tasks and documentation
  • Analytical and problem-solving skills
  • Collaboration and teamwork abilities


Requirements


  • Relevant educational background and experience in patient safety or related field
  • Strong presentation and communication skills
  • Effective intercultural work capabilities
  • Commitment to timely completion of tasks and documentation
  • Analytical and problem-solving skills
  • Collaboration and teamwork abilities



Salary: 300000 - 500000

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