Senior Associate – Pharmacovigilance (US, Remote)
Function: Pharmacovigilance / Drug Safety
Company: Worldwide Clinical Trials
Location: United States (Remote / Home-Based)
Base Location Reference: Durham, North Carolina, USA
Employment Type: Full-Time
Experience Required: Minimum 5 Years (Clinical Trial Pharmacovigilance)
Start Date: 29 November 2025
Application Deadline: 29 December 2025
Compensation: Competitive (Industry-aligned)
Role Overview
Worldwide Clinical Trials, a globally recognized mid-sized Contract Research Organization (CRO), is seeking a Senior Associate – Pharmacovigilance to join its US-based remote drug safety team. This role is critical in supporting pre-approval clinical trial pharmacovigilance activities, ensuring regulatory compliance, data quality, and patient safety throughout the clinical development lifecycle.
As a senior contributor, you will work cross-functionally with internal teams, global investigators, sponsors, and regulatory authorities, playing a pivotal role in the end-to-end safety management of investigational products.
Key Responsibilities
Author and maintain Safety Management Plans (SMPs) for assigned clinical studies.
Review incoming Serious Adverse Event (SAE) data for completeness, medical accuracy, and regulatory compliance.
Perform data entry and tracking of safety information within validated safety databases.
Generate and manage queries for missing, inconsistent, or unclear safety data, coordinating follow-up with investigational sites.
Conduct quality control (QC) reviews of SAEs processed by other pharmacovigilance associates.
Prepare, generate, and submit regulatory safety reports, including expedited and periodic reports, as required.
Support preparation and submission of Periodic Safety Reports in accordance with global regulations.
Attend and contribute to internal meetings, client discussions, investigator meetings, and project kick-off sessions.
Maintain current knowledge of global pharmacovigilance regulations and guidelines (FDA, ICH, EMA).
Support project scope awareness, budget considerations, and escalation of scope changes when identified.
Contribute to bid defenses, presentations, and client-facing documentation as needed.
Mentor, train, and provide guidance to junior pharmacovigilance team members.
Perform additional pharmacovigilance duties aligned with business and project needs.
Required Qualifications & Experience
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related scientific discipline (or equivalent experience).
Minimum 5 years of hands-on pharmacovigilance experience, specifically within pre-approval clinical trials.
Strong understanding of medical and scientific terminology, adverse event assessment, and global safety reporting requirements.
Demonstrated expertise in international pharmacovigilance regulations and compliance standards.
Proven experience working with validated safety databases and relational database systems, including data extraction.
Advanced computer literacy with strong proficiency in Microsoft Excel, Word, and PowerPoint.
Excellent written and verbal English communication skills.
Ability to work independently while thriving in a matrixed, global team environment.
Strong organizational skills with the ability to manage multiple priorities under tight timelines.
Willingness to travel occasionally (domestic and international) for investigator meetings, project kick-offs, or bid defenses, if required.
Why Join Worldwide Clinical Trials
Be part of a globally respected CRO involved in the complete lifecycle of drug development.
Work in a remote-first environment supporting work–life balance.
Collaborate with experienced pharmacovigilance professionals across regions and therapeutic areas.
Contribute directly to patient safety and regulatory success of investigational products.
Inclusive, collaborative, and innovation-driven workplace culture.
Diversity, Equity & Inclusion
Worldwide Clinical Trials is an equal opportunity employer committed to building a diverse and inclusive workforce. All qualified applicants will receive equal consideration without regard to race, gender, age, disability, sexual orientation, nationality, or any other legally protected status.
How to Apply
Qualified candidates are encouraged to apply through the official application channel before the closing date. Professionals who meet most—but not all—criteria are still encouraged to apply, as Worldwide values capability, growth potential, and expertise.
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Kyiv |Lima Region :
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Paris | Lyon |South Africa :
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Niš |Bohemia :
Prague |Chile :
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