Job Title: Associate II, Pharmacovigilance
Company: Worldwide Clinical Trials
Location: Remote (UK/EU)
Salary: Competitive
Start Date: 11 April 2025
Closing Date: 11 May 2025
About the Company:
Worldwide Clinical Trials is a global mid-sized Contract Research Organization (CRO) with a mission to improve lives through innovative and high-quality drug development. Comprising over 3,500 experts worldwide, the company is committed to a culture that values passion, creativity, diversity, and collaboration.
Department Overview – Pharmacovigilance:
The Pharmacovigilance (PV) department ensures drug safety throughout the entire lifecycle—from First in Human studies to global regulatory approvals. The team is responsible for reviewing, analyzing, and submitting safety data to Investigators, Ethics Committees, IRBs, and Regulatory Agencies.
Key Responsibilities:
Author Safety Management Plans for assigned studies
Attend internal and client meetings as required
Review incoming Serious Adverse Event (SAE) data for accuracy and completeness
Perform data entry in Safety Database or maintain relevant tracking systems
Generate and follow up on queries for incomplete or unclear safety data
Perform quality control (QC) on SAEs processed by other associates
Generate regulatory reports and carry out safety submissions
Prepare and submit periodic safety reports
Maintain up-to-date knowledge of global safety regulations and guidelines
Requirements:
Skills & Knowledge:
Strong grasp of medical and scientific terminology
Understanding of clinical assessment of adverse drug events and international regulatory requirements
Proficiency in managing relational database systems and data extraction
Strong organizational skills and ability to manage competing priorities
Excellent interpersonal, verbal, and written communication skills
Demonstrated professionalism, adaptability, and reliability in daily tasks
Qualifications & Experience:
Bachelor’s degree in a science-related field, nursing, or equivalent
Minimum 1 year of pharmacovigilance experience (focused on pre-approval clinical trials)
Proficient in Microsoft Office (Excel, Word, PowerPoint)
Equivalent combinations of education and relevant experience will be considered
Worldwide Clinical Trials is an equal opportunity employer that embraces diversity and inclusion to ensure professionals from all backgrounds can thrive. The organization fosters an environment where employees are respected and empowered to succeed.
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