Instagram
youtube
Facebook

Drug Safety Associate Ii, Pharmacovigilance - Us - Remote

0-2 years
Not Disclosed
10 Feb. 11, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Drug Safety Associate II, Pharmacovigilance – US (Remote)

Employer: Worldwide Clinical Trials – USA
Location: Durham, North Carolina, United States (Remote)
Salary: Competitive
Start Date: 16 Jan 2025
Closing Date: 15 Feb 2025

About Worldwide Clinical Trials

At Worldwide Clinical Trials, we are not just a midsize CRO—we are pioneers in clinical research, dedicated to pushing boundaries and delivering innovative solutions to some of the world’s most challenging diseases. Our team of 3,500+ experts is united by a passion for improving lives, and we are looking for individuals who share this same mission.

Why Join Us?

We believe in empowering professionals from diverse backgrounds by providing an inclusive, collaborative, and supportive work environment. Our leaders are accessible, our teams are cohesive, and we are dedicated to ensuring everyone thrives in their role.

Role Overview

As a Drug Safety Associate II in Pharmacovigilance, you will play a critical role in processing, evaluating, and reporting Serious Adverse Events (SAEs). You will be responsible for summarizing case narratives, determining regulatory reporting status, and managing safety data within the Drug Safety Database. You will also assist in preparing periodic safety reports for regulatory authorities and contribute to safety signal detection.

Key Responsibilities

  • Evaluate SAE case information, determine regulatory reporting status, and enter data into the safety database.
  • Provide retrieval and reporting of safety data from the global database.
  • Assist in preparing Safety Update Reports (ASRs, Periodic Line Listings) and other regulatory reports.
  • Collaborate with Clinical Operations, Data Management, and other teams for database reconciliation.
  • Ensure compliance with global SOPs and local regulations for handling safety data.
  • Support the development of study-specific Safety Monitoring Plans.
  • Contribute to safety signal generation and evaluation through data analysis.
  • Stay updated on drug safety laws, regulations, and guidelines.

Required Qualifications & Skills

  • Bachelor’s degree in a science-related field or nursing.
  • Strong knowledge of medical and scientific terminology.
  • Understanding of clinical assessment of adverse drug events and global pharmacovigilance regulations.
  • Proficiency in relational database management and data extraction.
  • Excellent oral and written communication skills.
  • Strong time management and organizational skills.
  • Ability to work independently and handle complex safety data.

What We Offer

At Worldwide Clinical Trials, we prioritize employee well-being and career development. We offer:

  • A collaborative and inclusive work environment.
  • Opportunities to advance your career in pharmacovigilance.
  • Access to cutting-edge clinical research projects.

Apply Now

We love knowing that our work directly improves lives. If you are passionate about drug safety and pharmacovigilance, apply today!

To explore other opportunities, visit our careers page: Worldwide Careers.

Worldwide Clinical Trials is an equal opportunity employer, committed to diversity, inclusion, and equal access to opportunities for all applicants.