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Associate Ii, Pharmacovigilance- Europe- Remote

3+ years
Not Disclosed
10 Oct. 15, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Who We Are

At Worldwide Clinical Trials, we are a global midsize CRO dedicated to pushing boundaries and innovating in the pursuit of cures for the world’s most persistent diseases. We believe that significant breakthroughs come from those who take creative risks and implement them with quality and excellence. With a diverse team of over 3,500 experts, we are transforming the way the world experiences CRO services—making it better for everyone involved.

Our Mission

We work with passion and purpose every day to improve lives, and we seek individuals who share this commitment. Everyone at Worldwide plays a vital role in making a difference for patients and their caregivers. From accessible leadership to cohesive teams, we foster a diverse and inclusive environment that promotes collaboration and creativity. We take pride in being a workplace where individuals can thrive by being their authentic selves, inspiring one another to achieve their best work every day. Join us!

What You Will Do

  • Author Safety Management Plans for assigned studies.
  • Attend internal and client meetings, presenting at Investigator Meetings as appropriate.
  • Review incoming Serious Adverse Event (SAE) data for completeness and accuracy, performing quality control on SAEs processed by other pharmacovigilance associates.
  • Enter data in the Safety Database and track incoming safety information.
  • Generate queries for missing or unclear information and follow up with sites for resolution.
  • Prepare and submit periodic safety reports and other regulatory submissions as needed.

What You Will Bring to the Role

  • A solid understanding of medical and scientific terminology, principles of clinical assessment of adverse drug events, and international regulations related to reporting requirements.
  • Familiarity with computer technology and relational database management, including data extraction.
  • A positive attitude and the ability to interact professionally with internal and external customers in a global environment.
  • Excellent organizational skills with the ability to manage multiple competing priorities within tight deadlines.

Your Background

  • Bachelor’s degree in a science-related field, nursing, or equivalent.
  • A minimum of 3 years of pharmacovigilance experience, preferably in pre-approval clinical trials.
  • Proficiency in MS Office applications (Excel, PowerPoint, Word).
  • Excellent written and verbal communication skills.

Join Us in Making a Difference

We love knowing that our work contributes to better lives for individuals everywhere. To explore other opportunities with us, visit our careers page at Worldwide. For more information about our mission and values, check out our website at www.Worldwide.com or connect with us on LinkedIn.