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Senior Associate, Pharmacovigilance - Us - Remote

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ICON
5+ years
Not Disclosed
10 Dec. 22, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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 Associate, Pharmacovigilance – US (Remote) | Worldwide Clinical Trials
Location: Durham, North Carolina, United States (Remote / Homeworking)
Salary: Competitive
Start Date: 29 Nov 2025
Application Deadline: 29 Dec 2025

Company Overview:
Worldwide Clinical Trials is a global midsize CRO dedicated to advancing drug development through innovative, high-quality solutions. With over 3,500 professionals worldwide, we combine expertise, creativity, and dedication to improve patient outcomes. Our mission is to transform clinical research by fostering an inclusive environment where employees thrive and deliver excellence every day.

Why Join Worldwide Clinical Trials:
We value every team member’s contribution and promote a collaborative, diverse, and supportive workplace. From hands-on leadership to cross-functional teamwork, we encourage innovation, creativity, and professional growth. Worldwide Clinical Trials is a place where your expertise impacts patient safety and clinical outcomes globally.

Pharmacovigilance at Worldwide:
Our Pharmacovigilance (PV) team is central to ensuring drug safety across all stages of clinical development—from First in Human studies to global regulatory approval. The team reviews safety events globally, analyzing and reporting data to Investigators, Ethics Committees/IRBs, and Regulatory Agencies. This role allows you to be directly involved in the lifecycle of investigational drugs, supporting patient safety and regulatory compliance.

Key Responsibilities:

  • Author Safety Management Plans for assigned studies.

  • Participate and present at internal and client meetings, including Investigator Meetings.

  • Review incoming SAE data for completeness and accuracy; perform data entry in safety databases.

  • Generate and resolve queries for missing or unclear safety information.

  • Conduct quality control of SAEs processed by other PV associates.

  • Prepare and submit regulatory reports, including periodic safety reports.

  • Maintain up-to-date knowledge of safety regulations and clinical trial guidelines.

  • Assist with budget and scope management for assigned projects, escalating potential changes.

  • Mentor or train junior PV staff as needed.

  • Perform other PV-related duties as assigned.

Qualifications and Skills:

  • Bachelor’s degree in a science-related field, nursing, or equivalent; advanced degree preferred.

  • Minimum of 5 years of pharmacovigilance experience, particularly in pre-approval clinical trials.

  • Strong understanding of medical terminology, adverse event assessment, and international PV regulations.

  • Proficiency in computer technology and relational database management systems.

  • Excellent organizational skills, with the ability to manage multiple priorities under tight deadlines.

  • Strong analytical and problem-solving skills with a solutions-focused mindset.

  • Excellent written and verbal communication skills in English.

  • Ability to work independently and collaboratively in a matrix team environment.

  • Willingness for occasional domestic or international travel as required.

What Worldwide Clinical Trials Offers:

  • Competitive salary and benefits package.

  • Inclusive and collaborative work culture fostering professional growth.

  • Opportunities to work on cutting-edge clinical trials with global impact.

  • Access to ongoing training and mentorship in pharmacovigilance and clinical research.

Diversity & Inclusion:
Worldwide Clinical Trials is committed to diversity, equity, and inclusion. We provide equal employment opportunities regardless of race, color, ethnicity, religion, gender, sexual orientation, age, disability, veteran status, or any other protected status. We believe diverse teams drive innovation, creativity, and success.

Apply Now to join a global leader in pharmacovigilance and contribute to improving patient outcomes worldwide.