Global Safety Operations Lead
1 month ago
This role offers a unique opportunity to work with the Global Drug Safety & Pharmacovigilance team at Genmab. Based in Copenhagen, Denmark, we are seeking a skilled professional to lead our safety operations.
Job SummaryWe are looking for an experienced Drug Safety professional to oversee the successful and timely case intake of safety reports and case processing. The ideal candidate will have a minimum of 5 years of experience within drug safety and PV, including case quality control and regulatory submissions of ICSRs worldwide.
About This RoleThis is a hybrid position located in Copenhagen, Denmark. As a key member of our team, you will be responsible for performing ongoing and real-time quality control review of safety case data entry in the safety database. You will also provide guidance on questions around safety operations based on company conventions, ICH, and regulatory guidance.
Your Responsibilities- Oversight of case intake and processing to ensure compliance with regulatory requirements
- Quality control review of safety case data entry to maintain accuracy and integrity
- Guidance on safety operation-related questions and concerns
- Development and update of Standard Operating Procedures and training materials
- SAE Reconciliation activities management, including review and approval of reconciliation plans
- Effective management of safety case workload to ensure timely compliance with regulatory submissions
- Investigation of deviations and monitoring of CAPAs relating to non-compliance issues
- Resolution of open and answered safety queries in the EDC
To succeed in this role, you should have excellent analytical and strategic thinking skills. You will be a strong collaborator who can work effectively in a fast-paced environment. Experience working in a dynamic company or a strong desire to do so is highly valued.
Requirements- Minimum 5 years of experience in drug safety and PV
- Good knowledge of ICH E2B(R2) and (R3) specifications and entry guidance
- Ability to interpret health and medical records
- Experience with clinical and post-marketing case processing
- Experience with MedDRA and WHO DD coding and narrative writing
- Analytic and strategic thinking
- Excellent attention to detail
Genmab offers a competitive salary, ranging from 120,000 to 180,000 DKK per year, depending on experience. In addition to a comprehensive benefits package, you will have opportunities for professional growth and development in a collaborative and innovative environment.
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