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Associate Ii, Pharmacovigilance - Uk/Eu - Remote

1+ years
Not Disclosed
10 April 29, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.