Senior Associate, Pharmacovigilance (Remote – United States)
Employer: Worldwide Clinical Trials
Location: United States (Remote)
Job Category: Pharmacovigilance / Drug Safety
Experience Required: Minimum 5 years in Pharmacovigilance (Clinical Trials – Pre-Approval)
About the Company
Worldwide Clinical Trials is a global, mid-size Contract Research Organization dedicated to accelerating clinical development through scientific innovation, operational excellence, and patient-centric strategies. With a team of more than 3,500 professionals across the world, the organization supports the development of breakthrough therapies that address complex and persistent diseases.
Role Overview
The Senior Associate, Pharmacovigilance plays a key role in ensuring patient safety throughout clinical development. This remote role supports global clinical trial programs by managing safety data, performing case processing activities, generating safety reports, and collaborating with cross-functional teams to ensure regulatory compliance.
This opportunity is ideal for experienced pharmacovigilance professionals seeking a collaborative, growth-focused environment within a leading CRO.
Key Responsibilities
Develop and author Safety Management Plans for assigned clinical studies.
Participate in internal meetings, client discussions, and Investigator Meetings as required.
Review Serious Adverse Event (SAE) data for completeness, quality, and regulatory accuracy.
Enter safety information into global safety databases and maintain accurate documentation.
Raise and track queries for missing or unclear safety data and follow up with clinical sites.
Perform quality control checks on SAEs and case reviews completed by other PV team members.
Generate and submit regulatory safety reports, including expedited and periodic reports.
Stay updated on global safety regulations, guidelines, and best practices.
Monitor project scope, timelines, and budget adherence, ensuring proactive escalation of risks.
Support bid defense meetings and contribute to client presentations.
Mentor and train new pharmacovigilance associates as needed.
Required Qualifications & Experience
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline.
Minimum of 5 years of pharmacovigilance experience in pre-approval clinical trials.
Strong understanding of medical terminology, adverse event assessment, reporting guidelines, and global PV regulations.
Proficiency in safety database use and data extraction, along with strong MS Office skills (Excel, Word, PowerPoint).
Excellent written and verbal communication skills.
Ability to work independently, manage priorities, and perform effectively in a matrix environment.
Ability to travel occasionally within the US or internationally for Investigator Meetings or project kick-offs.
Fluency in English (written and spoken).
Preferred Skills
Strong analytical mindset with attention to accuracy and compliance.
Capability to handle multiple deadlines in a fast-paced environment.
Collaborative attitude with professional communication skills.
Experience mentoring junior PV staff is an advantage.
Why Join Worldwide Clinical Trials
Work within a global pharmacovigilance team contributing directly to drug safety and clinical development.
Engage in meaningful work that impacts patient care and regulatory decision-making.
Opportunity to grow within a supportive, inclusive environment that values diversity and innovation.
Access to collaborative leadership and professional development opportunities.
Application Information
To explore this opportunity and other openings, visit the Worldwide Clinical Trials Careers Page. Worldwide Clinical Trials is an equal opportunity employer committed to creating a diverse and inclusive workplace.
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