Medical Data Specialist

1 month ago

Pune, Maharashtra, India EVERSANA Full time
Overview of the Role

We are seeking a highly skilled Medical Data Specialist to join our Pharmacovigilance team at EVERSANA. In this role, you will be responsible for processing and analyzing safety data from clinical trials and spontaneous post-marketing reports.


Job Description

This position is part of our client Pharmacovigilance Department and will work closely with PV Management and Project Managers to meet client project deadlines. As a key member of the team, you will support the efficient management of workload and ensure timely reporting to Regulatory Authorities and other stakeholders.


Duties and Responsibilities
  • Facilitate communication between PV Management, Project Managers, and team members to ensure seamless project execution.
  • Independently assess adverse events to determine reportability and establish an accurate clinical assessment of cases.
  • Analyze and code adverse events in MedDRA using clinical judgment and medications to WHODRUG.
  • Create draft narratives of events based on case descriptions provided by reporters, applying basic rules of grammar to improve content.
  • Formulate follow-up queries and ensure regulatory compliance with timelines for individual expedited case report submissions.

Requirements
  • Bachelor's degree in a life science discipline (e.g., pharmacy, nursing) or equivalent experience.
  • 5 years of relevant experience, including 3 years in drug safety.
  • Broad knowledge of domestic and international drug safety regulations, industry practices, and standards.
  • Strong attention to detail, teamwork, and initiative.

Benefits and Qualifications
  • A competitive estimated salary of $80,000 per year.
  • Opportunities for growth and professional development in a dynamic and innovative company.
  • A positive work environment that values diversity, equity, and inclusion.
  • The ability to make a meaningful impact on patient lives through your work.

About EVERSANA

EVERSANA is a global company committed to creating a healthier world through next-generation commercialization services. With over 7,000 employees worldwide, we serve more than 650 clients across the life sciences industry. Our culture is built on a strong foundation of diversity, equity, and inclusion, and we believe that our people make all the difference in cultivating an inclusive culture that embraces our values.

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