Pharmacovigilance Associate II
2 semanas atrás
Job Overview: We are seeking a detail-oriented and proactive Pharmacovigilance Associate II to support Clinical Trial and Post-Approval Case Processing Activities. The primary responsibility of this role is to collect and process safety data through outreach to healthcare providers and consumers, ensuring compliance with regulatory requirements and internal procedures. Summary of Responsibilities: Manage receipt and processing of all adverse event reports, whether spontaneous or from a clinical trial. This includes but is not limited to:Conduct outbound follow‑up requests to healthcare professionals and consumers to collect post‑approval safety data via email or fax. Identify clinically significant missing information in reports and ensure its collection and follow‑up. Review adverse event reports for completeness, accuracy, and expedited reporting requirements. Enter safety data into adverse event database(s) and tracking systems. Ensure all cases requiring expedited reporting to worldwide regulatory agencies and other required parties are processed swiftly within required timelines. Support additional activities such as data tracking, quality control training, and data reconciliation. Maintain a comprehensive understanding of SOPs, WI, guidance documents, and directives related to safety management reporting and pharmacovigilance. Support root‑cause analysis and CAPA plan development & implementation for identified quality issues as needed. Support and/or participate in audits and inspections, including preparation as required. Demonstrate role‑specific core competencies and company values, maintaining good PSS relationships across functional units. Undertake any other duties as needed. Qualifications (Minimum Required): Degree in one of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences. Associate’s degree with 2 years of safety experience, or equivalent. BS/BA with 2 years of safety experience, or equivalent. MS/MA with 2 years of safety experience, or equivalent. PharmD with 2 years of safety experience. Experience (Minimum Required): Advanced command of English language (speaking, writing, reading). Proven expertise in processing U.S. post‑approval cases is mandatory. Proficient with the Argus safety database. Strong typing ability and familiarity with Microsoft Office Suite and Windows environment is advantageous. Strong attention to detail with a high degree of accuracy. Ability to work independently with minimal supervision. Good understanding of ICH guidelines and global regulatory requirements for the reporting of adverse events for both marketed and investigational products. Learn more about our EEO & Accommodations request here. Required Experience: IC #J-18808-Ljbffr
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