Senior Associate – Pharmacovigilance (US Remote)
Employer: Worldwide Clinical Trials
Location: United States (Remote / Home-Based; Durham, NC listed)
Job Type: Full-Time
Salary: Competitive, based on experience
Start Date: 29 November 2025
Application Deadline: 29 December 2025
Job Overview
Worldwide Clinical Trials, a global mid-sized Contract Research Organization (CRO), is seeking an experienced Senior Associate, Pharmacovigilance to support clinical trial drug safety activities across global programs. This US-based remote role offers the opportunity to work across the full clinical development lifecycle, from first-in-human studies through regulatory submissions.
The Senior Associate, Pharmacovigilance will play a critical role in safety oversight, regulatory reporting, quality control, and stakeholder collaboration to ensure patient safety and compliance with international regulatory requirements.
About Worldwide Clinical Trials
Worldwide Clinical Trials is a global CRO with over 3,500 professionals worldwide, committed to advancing therapies for some of the world’s most challenging diseases. The organization is known for its hands-on leadership, collaborative culture, and focus on innovation, quality, and patient impact.
Key Responsibilities
Author and maintain Safety Management Plans (SMPs) for assigned clinical studies
Review incoming Serious Adverse Event (SAE) reports for accuracy, completeness, and regulatory compliance
Perform data entry and case processing in pharmacovigilance safety databases and tracking systems
Generate and manage queries for missing or unclear safety information and follow up with investigational sites
Perform quality control (QC) review of safety cases processed by other pharmacovigilance associates
Prepare, generate, and submit regulatory safety reports to health authorities, IRBs, Ethics Committees, and investigators
Prepare and submit periodic safety reports, including DSURs, as required
Participate in internal, client, and investigator meetings, including presenting safety information when needed
Maintain current knowledge of global pharmacovigilance regulations, guidelines, and reporting requirements
Support project scope, timelines, and budget awareness, escalating any potential changes as required
Contribute to bid defenses, project kick-off meetings, and client presentations as needed
Mentor, train, and support junior pharmacovigilance staff
Perform additional pharmacovigilance-related duties as assigned
Required Qualifications and Experience
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related scientific discipline
Minimum 5 years of pharmacovigilance experience, specifically within pre-approval clinical trials
Strong knowledge of adverse event assessment, medical terminology, and global safety reporting requirements
In-depth understanding of international pharmacovigilance regulations and guidelines (FDA, ICH, EMA)
Hands-on experience with pharmacovigilance safety databases and relational data systems
Strong proficiency in Microsoft Office applications (Excel, Word, PowerPoint)
Excellent written and verbal communication skills in English
Proven ability to work independently while managing multiple priorities in a matrix team environment
Strong organizational, problem-solving, and decision-making skills
Ability to provide and receive constructive feedback professionally
Willingness to travel occasionally (domestic or international) for investigator meetings or project activities, if required
Why Join Worldwide Clinical Trials
Worldwide Clinical Trials fosters a supportive, inclusive, and high-performance work environment where employees are empowered to make a meaningful difference in patient lives. The organization values collaboration, innovation, and professional growth, offering employees the opportunity to work on impactful global clinical programs.
Diversity, Equity, and Inclusion
Worldwide Clinical Trials is an equal opportunity employer committed to diversity, equity, and inclusion. Employment decisions are made without regard to race, color, ethnicity, religion, gender, sexual orientation, gender identity, age, disability, military status, or any other protected status under applicable laws. Reasonable accommodations are available throughout the recruitment process upon request.
Application Information
Qualified candidates are encouraged to apply before the closing date. Candidates who may not meet every listed requirement but bring relevant experience and strong potential are still encouraged to apply.
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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