Associate, Pharmacovigilance Operations/Drug Safety

Summary:

• Responsible for reviewing adverse events and assisting in the determination of regulatory reporting for assigned investigational products
• May serve as a liaison to internal and external stakeholders for AE reporting issues (i.e. site staff, CRAs, case processing vendor)
• Works in collaboration with other functional groups such as data management, clinical operations, regulatory affairs, quality, and medical affairs

Key Responsibilities:

• Serves as the main point of contact for any adverse event questions, requests, and/or reviews within the safety and clinical databases
• Initial review of incoming initial and follow up SAE/AESI reports and issues clinically appropriate queries as needed
• Perform quality control checks and finalization step for each case entered in the Argus database
• Assists in the day-to-day oversight of the case processing vendor including the monitoring of KPIs for vendor assessment
• Serves as the point of contact for any issues noted in the safety database and generates Help Desk tickets when appropriate
• Assists in the preparation of safety reports to be submitted to regulatory agencies
• Assists with literature review, as required
• Evaluation of existing data points and generation of follow-up queries for all reports within protocol specified timelines
• Ensures consistency in the evaluation and assessment of AE reports for completeness, accuracy and legibility for case entry
• Exercises judgement and use of knowledge of FDA and ICH guidelines in performing case reviews
• Contributes to coding of medical terms, procedures, and concomitant medications in a consistent and timely manner
• Maintains contemporaneous status within the eTMF as it relates to relevant safety communications and documents
• Generate scheduled reports from the safety database to share with clinical team as well as fulfilling any ad hoc requests
• Provide subject matter expertise on adverse events
• Attends and contributes to internal meetings as appropriate for role
• Assists in various projects as assigned by direct supervisor and/or PV department leadership
• Review and create study related documents such as Safety Management Plans, safety summaries, and SAE reconciliation

Required Qualifications

• A minimum degree of bachelor's or higher degree in a clinical or closely related field
• 2-3 years of related experience gained in a biotech or pharmaceutical company
• 1-2 years of experience in cellular therapy, stem cell transplant, and/or oncology strongly strongly preferred
• Post-marketing experience desirable
• Proficiency in the Argus safety database system
• Working knowledge of MedDRA and WHODrug coding preferred
• Veeva Vault experience preferred
• Excellent written and verbal communication skills
• Strong attention to detail
• Excellent organizational and prioritization skills
• Ability to work independently and in a team setting
• Ability to manage day-to-day operations as well as special projects within a growing company
• Fluent in medical terminology, preferred