Associate II, Pharmacovigilance – UK/EU – Remote
Employer: Worldwide Clinical Trials
Location: United Kingdom (Remote)
Job Type: Full-time
Start Date: 11 April 2025
Closing Date: 11 May 2025
About Worldwide Clinical Trials:
Worldwide Clinical Trials is a global mid-sized CRO with over 3,500 professionals committed to transforming the landscape of drug development. With innovation, creativity, and passion, we strive to develop cures for the world’s most persistent diseases. Our collaborative and diverse team fosters a supportive environment where individuals thrive and make a genuine impact.
About the Pharmacovigilance Department:
Our Pharmacovigilance (PV) team is instrumental in ensuring drug safety throughout a compound's lifecycle—from First in Human trials to regulatory approval. By managing and analyzing safety events, we support clinical drug development in collaboration with regulatory authorities, investigators, and ethics committees.
Key Responsibilities:
Author Safety Management Plans for assigned clinical studies.
Attend internal and client meetings as appropriate.
Review incoming Serious Adverse Event (SAE) data for accuracy and completeness.
Perform data entry into safety databases and track safety information.
Generate follow-up queries for missing or unclear information and liaise with clinical sites for resolution.
Conduct quality control (QC) checks of SAEs processed by other PV Associates.
Generate regulatory reports and handle safety submissions.
Prepare and submit periodic safety reports (PSURs) as needed.
Stay updated with safety regulations, standards, and reporting requirements.
Required Qualifications and Skills:
Bachelor’s degree in life sciences, nursing, or a related field (or equivalent experience).
Minimum 1 year of experience in pharmacovigilance within pre-approval clinical trials.
Good understanding of medical/scientific terminology and adverse event assessment principles.
Familiarity with international regulatory reporting requirements.
Strong computer proficiency including MS Office (Excel, Word, PowerPoint).
Excellent written and verbal communication skills.
Highly organized with the ability to manage competing priorities and meet tight deadlines.
Demonstrated professionalism, adaptability, and dependability in a global, collaborative environment.
Why Join Worldwide:
A mission-driven organization focused on improving lives globally.
Supportive leadership and a collaborative team environment.
Commitment to diversity, equity, and inclusion.
Recognition for your contributions to meaningful global healthcare advancements.
Equal Opportunity Employer:
Worldwide Clinical Trials is committed to providing equal employment opportunities to all, regardless of race, gender, sexual orientation, disability, veteran status, or any other protected characteristic. We strive to create an inclusive environment that fosters creativity, collaboration, and innovation.
Learn More:
Visit www.Worldwide.com or explore more roles on our careers page.
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