Summary of The Position: The Senior Pharmacovigilance Associate (sPVA) I, works under minimal supervision, and is responsible for the pharmacovigilance activities on project-level in accordance with applicable guidelines, regulations, and Standard Operating Procedures (SOPs) and is overseen and supported by the designated project Research Physician. The sPVA also functions in a supportive role to the Pharmacovigilance Manager and Associate Director, Pharmacovigilance or designee/s across the spectrum of departmental activities, performing diversified functions as required, in accordance with qualification competence. The purpose of the SPVA on departmental level is to provide training to and mentoring of PV Associates. The overall objective is to ensure that the Pharmacovigilance Department of FHI Clinical functions optimally and effectively to foster good quality safety data and safety surveillance per project in compliance with ICH Good Clinical Practices (GCP), SA GCP and local legal requirements, European, FDA and other international guidelines, as well as FHI Clinical (or sponsor, if applicable) SOPs.

Education:

• Bachelors or higher graduate degree. A degree in a medical/science-related field is preferred.
• In lieu of a degree, an equivalent combination of diplomas, certifications, or relevant work experience is required.
• Licensed or certified health care training will be beneficial.

Preferred Job-related Experience:

• A minimum of three (3) years of experience as a PVA or in a clinical research setting is preferred.
• Broad experience as a PVA performing services on complex studies is preferred.
• A track record of excellence in terms of quality and delivery is preferred.
• A reputation of sustained performance and accomplishment is preferred.

Additional Eligibility Qualifications:

• Experienced in Microsoft Office (i.e., Word, Excel, PowerPoint, Outlook, SharePoint, Teams, etc.).
• Experience with an EDC or CTMS is preferred.
• Knowledge and experience in at least one safety database in front-end use and trial-specific configuration.
• In-depth knowledge and understanding of theory and practice of safety monitoring.
• Ability to compile concise high-quality safety manuals and procedural documents.
• Ability to assess knowledge gaps in peers and to find appropriate opportunities to enable colleagues to gain the required experience.
• Able to determine the most appropriate methods and procedures when given a new assignment and able to take a leadership role in implementing the safety monitoring aspects of a clinical trial.
• Able to review reports, regulatory documents and other trial-related documentation to ensure documents meet required standards