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Pharmacovigilance Systems Administrator (Home-Based/Remote) Us

3-5 years
Not Disclosed
10 July 22, 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, 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

Worldwide Clinical Trials (Worldwide) is a premier global contract research organization (CRO) partnering with biotechnology and pharmaceutical companies to craft customized solutions that advance new medications from discovery through to reality. With a strong foundation in scientific excellence, we focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, developing flexible strategies to swiftly address our customers’ needs.

Our team of over 3,500 professionals operates in more than 60 countries, united in our mission to enhance patient lives through innovative therapies.

Why Worldwide

At Worldwide, we believe every individual plays a crucial role in making a difference for patients and their caregivers. Our approachable leaders, supportive teams, and commitment to diversity and inclusion foster an environment where professionals from all backgrounds can thrive. We are dedicated to promoting collaboration and creativity, making our workplace a space where people can be themselves and excel in their roles. Join us and be part of a team where your contributions are valued and your growth is encouraged.

What the Pharmacovigilance Department Does

Pharmacovigilance at Worldwide is pivotal to ensuring drug safety. Our team, comprising experts in Drug Safety, oversees drugs from their initial human administration to global regulatory approval. We manage safety events from around the world, collaborating with clients to review, analyze, and submit reports to Investigators, Ethics Committees/IRBs, and Regulatory Agencies, supporting the advancement of clinical drug development.

What You Will Do

  • Oversee the setup, management, and maintenance of Worldwide’s pharmacovigilance systems, ensuring compliance with SOPs, processes, and regulations.
  • Support daily operations of pharmacovigilance systems and troubleshoot complex issues.
  • Maintain a comprehensive understanding of pharmacovigilance systems across regions and provide guidance and coaching on their use.
  • Organize and deliver training sessions and participate in onboarding staff regarding pharmacovigilance systems.
  • Consult with PV management on complex pharmacovigilance data transfers for clients or potential clients.

What You Will Bring

  • Strong knowledge of computer technology and relational database management, including data extraction.
  • Familiarity with medical terminology.
  • A positive attitude with the ability to interact diplomatically and professionally with internal and external stakeholders in a global setting.

Your Experience

  • 3-5 years of experience with pharmacovigilance systems.
  • Advanced understanding of pharmacovigilance systems and safety databases.
  • Ability to work independently, effectively prioritize tasks, and succeed in a matrix team environment.
  • Proficiency in MS Office applications (Excel, PowerPoint, Word).

Why We Do It

We take pride in knowing our work helps improve lives. Explore our other opportunities and learn more about us at Worldwide Careers. For additional information, visit Worldwide or connect with us on LinkedIn.

Equal Opportunity

Worldwide is an equal opportunity employer dedicated to fostering a diverse and inclusive workforce. We offer equal employment opportunities to all individuals regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or any other class protected by applicable law. We are committed to providing reasonable accommodations to applicants with disabilities and creating a workplace where everyone can thrive and do their best