Senior Manager, Drug Safety Adverse Events of Special Interest (AESI) and Medical Evaluation

Job Description

About This Role

The Senior Manager, Drug Safety Adverse Events of Special Interest (AESI) and Medical Evaluation is accountable for supporting and executing the established strategies & processes to ensure AESI ICSRs and Medical Review of all ICSRs are managed with a high degree of quality and compliance and conducted in compliance with regulatory requirements and corporate and departmental procedures. The Senior Manager is responsible to ensure complete and accurate reporting of adverse event data to regulatory agencies and clinical trial investigator sites worldwide, as applicable. The Senior Manager provides quality oversight to Contract Research Organizations (CROs) involved in AESI case handling and ICSR medical review. Other key responsibilities include collaboration with a wide range of cross-functional teams such as Global Case Management (GCM), Global Medical Safety (GMS), Medical Coding, Medical Affairs, Technology and Data Insights (TADI), etc.

What You’ll Do

• Ensures all AESI case processing and medical review of ICSRs is in compliance with regulatory requirements, corporate and departmental procedures, and data handling conventions:
  • Supports AESI case processing activities including revising/developing controlled documents and processes
  • Executes and monitors case processing compliance through various monitoring reports and other oversight activities
  • Provides quality oversight and maintains quality metrics for CRO
  • Point of contact to manage day to day support of CROs including imaging vendor(s)
  • Point of contact for AESI ICSR data collection, ICSR management, and associated regulatory deliverables including build, maintenance and generation of line listings or other provision of aggregated data
  • SME support during inspections and audits
• Accountable for the day-to-day oversight of procedures in place for AESI case processing activities.
• Collaborates with the CPO and ICSR Processes Teams to ensure consistency and alignment between Case Processing and Medical Review with respect to vendor oversight and communications.
• Complete assessment and medical review of post-marketing and/or clinical trial adverse event reports within regulatory and departmental timelines and in accordance with Biogen procedures and conventions:
  • Ensures adequacy of recording, summarization, and handling of adverse events for marketed and developmental Biogen products
  • Assesses seriousness and expectedness for reported adverse events
  • Assesses company causality for relevant adverse events
  • Ensures accurate coding of adverse events
  • Ensures due diligence in characterizing adverse events
  • Authors analyses of similar events for select serious adverse reactions
• Monitors global case review activities to ensure adequate timeliness of medical review and case completion
• Conducts quality oversight of global case handling and medical review activities outsourced to a vendor

Who You Are

You are a PV professional with a clinical background and a minimum of 4 years’ experience in the pharmaceutical/biopharmaceutical industry. You have a strong background in PV and handling global ICSRs, with demonstrated ability to work collaboratively and effectively in a fast paced environment and with individuals at all levels within the organization. You have demonstrated ability to apply sound clinical judgement, act decisively on sensitive safety topics, operate independently with minimal supervision and demonstrate expertise in global ICSR handling from intake to distribution.

Qualifications

Education and Experience Requirements:

• Bachelor's degree or Advanced degree, preferably in life science, nursing, pharmacy or other healthcare related profession
• 4+ years of direct pharmacovigilance work in the pharmaceutical industry
• 3+ years in clinical setting preferred but not required
• Strong analytic ability to review, evaluate, interpret and synthesize clinical and safety data in both written and verbal format
• Strong proficiency in verbal and written communication with great attention to detail
• Ability to work independently, manage priorities, build collaborative team relationships at all levels and remain flexible to the needs of the teams/ projects. Must be able to work on multiple projects simultaneously
• Solid understanding of worldwide post-marketing and clinical trial adverse event regulations.
• Demonstrate flexibility in adapting to changing global regulation and business priorities
• Demonstrate excellent communication skills.
• Ability to mentor, oversee and provide leadership to other staff members, as applicable
• Working knowledge of GCP and GVP regulations, MedDRA