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Senior Drug Safety Associate

5+ years
5-6 lakh per annum
10 Jan. 31, 2025
Job Description
Job Type: Full Time Education: BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

📌 Senior Drug Safety Associate | Pune
📍 Location: Pune, India
🕒 Experience: 5 years of relevant experience, including 3 years in drug safety.
💼 Company: EVERSANA

About EVERSANA

EVERSANA is a global leader in delivering next-generation commercialization services to the life sciences industry, striving to create a healthier world. With a team of more than 7,000 employees across 650 clients, EVERSANA is driven by its mission to improve patient lives around the world.

Role Overview

The Senior Drug Safety Associate supports the Pharmacovigilance (PV) department by processing and analyzing safety data from clinical trials and post-marketing reports. The role involves case management, adverse event tracking, regulatory compliance, and team collaboration.

Key Responsibilities

✔ Collaborate with PV Management/Project Manager to meet project deadlines and ensure timely regulatory reporting.
✔ Independently assess adverse events (AEs) for reportability, expectedness, seriousness, and causality using MedDRA and WHODRUG.
✔ Draft narratives, formulate follow-up queries, and perform Quality Control (QC) checks on the safety database.
✔ Lead and mentor junior team members, ensuring efficient case processing and reporting.
✔ Assist with aggregate reports, ad-hoc reports, and other regulatory documents.
✔ Contribute to regulatory compliance by meeting submission timelines for expedited case reports.
✔ Participate in client interactions, data reconciliation, and training efforts within the team.

Qualifications

🎓 Education: BS degree in a life science discipline (e.g., Pharmacy, Nursing) preferred.
💼 Experience:

  • Minimum 5 years of relevant experience, including 3 years in drug safety.
  • Strong understanding of MedDRA and WHODRUG coding.
  • Familiarity with FDA and international adverse event reporting regulations.
  • Knowledge of drug development and safety reporting standards.

Key Skills

  • Communication: Strong ability to articulate ideas and foster a collaborative environment.
  • Attention to Detail: Must demonstrate precision and quality in all tasks.
  • Leadership: Ability to lead and mentor team members while fostering initiative.

Additional Information

EVERSANA prioritizes Diversity, Equity, and Inclusion and is an Equal Opportunity Employer. They are committed to providing a secure and inclusive work environment.

📩 Apply Now