Senior Manager, Global Drug Safety & Pharmacovigilance, Safety Operations

Senior Manager, Global Drug Safety & Pharmacovigilance, Safety Operations

Genmab

Copenhagen, Denmark

The Role:

A member of the Global Drug Safety & Pharmacovigilance team, focused on safety operations including but not limited to collection of safety information from various sources, SAE reconciliation, quality control of safety data entry, and compliance of individual case safety reports (ICSRs) to regulatory authorities and business partners.

Responsibilities:

• Ensure the successful and timely case intake of safety reports and case processing.
• Perform both real-time and retrospective quality control of safety case data entry to ensure quality and compliance with the data entry conventions and MedDRA/WHO DD coding conventions.
• Effectively manage the daily safety case workload to ensure compliance with regulatory submissions and internal timelines including, but not limited to:
  • Monitoring the workflow status of safety cases and/or the pending regulatory submissions of ICSRs.
  • Communicating to safety vendor, safety physicians, and/or submission stakeholders as needed.
• Serve as a Subject Matter Expert and/or provide guidance on questions concerning Safety Operations based on, not only company conventions, but also ICH and regulatory guidance as well as best PV practices.
• Ensure the reporting destinations are correctly populated for each safety case and approve a regulatory report for all destinations in the safety database as applicable and proactively identify/resolve issues potentially leading to late reports.
• Perform and/or support regular trending and analysis quality data and compliance metrics to identify potential issues and propose long-term strategies for quality improvement or issue resolution.
• Review and provide input on behalf of Safety Operations on individual study-specific documents including but, but not limited to, Safety Operational Management Plan, SAE Reconciliation Plan, Data Validation Plan, and Safety Reporting Form Specifications Document.
• Perform and/or oversee individual study-specific set-up and maintenance activities like Sponsor eCRF acceptance testing, SAE Reconciliation activities, back-up Safety Reporting Form creation, and supporting the generation of automated line listing reports.
• Analyze and provide reason(s) for late submission/distribution of safety reports, as applicable.
• Perform and/or support the timely documentation, monitoring and closure of all owned Quality Events (Deviation, Change Control and/or Corrective Actions/Preventive Actions (CAPAs)).
• Develop or update Standard Operating Procedures, Working Instructions, and training materials concerning safety case processing and operations.
• Support GVP audit/inspection readiness initiatives and, in the event of an audit/inspection, support the preparation, execution, and responses to audit/inspection.
• Lead or participate in Genmab initiatives and projects on Safety Operations behalf.
• Other activities, as needed or as requested by supervisor.

Requirements:

Drug Safety professional with minimum 5 years of experience within drug safety and PV inclusive of case quality control and regulatory submissions of ICSRs worldwide.

• Bachelor’s/Master’s degree in science.
• Strong knowledge of ICH E2B(R2) and (R3) specifications and entry guidance.
• Strong knowledge of pharmacovigilance reporting rules and timelines.
• Ability to interpret health and medical records such as adverse event reporting forms, a discharge summary, etc.
• Experience with clinical and/or post-marketing case processing, including MedDRA and WHO DD coding and narrative writing.
• Experience with safety database; Argus is a plus but not mandatory.
• Experience with EDC for clinical trial data collection.
• Analytic and strategic thinking.
• Excellent in detailed-oriented tasks.

About You:

• You are genuinely passionate about our purpose.
• You bring precision and excellence to all that you do.
• You believe in our rooted-in-science approach to problem-solving.
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds.
• You take pride in enabling the best work of others on the team.
• You can grapple with the unknown and be innovative.
• You have experience working in a fast-growing, dynamic company (or a strong desire to).
• You work hard and are not afraid to have a little fun while you do so!