Genmab
Associate Director, Global Drug Safety & Pharmacovigilance, Safety Operations
DanmarkPosted 10 days ago
Full TimeExecutiveDK
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Job Description
Associate Director, Global Drug Safety & Pharmacovigilance, Safety Operations Location Copenhagen, Capital, Denmark Category Development Job Id R16980 Hybrid We are extra[not]ordinary *(ex· tra· not·
Key Highlights
- Responsible and accountable for day-to-day management of safety vendor and submission stakeholders involved in the lifecycle of a safety report.
- Oversee the successful and timely intake, processing, and submission of ICSRs to regulatory authorities, business partners, ethics committees, and investigators.
- Accountable for the case workload management and to ensure compliance with regulatory submissions and internal timelines.
- Serve as a Subject Matter Expert and/or provide guidance on questions escalated to management concerning Safety Operations. The responses are to be based on company conventions, ICH and regulatory guidance/requirements, and best PV practices.
- Oversee all communications received in Safety Operation Mailboxes and share all relevant updates across the Safety Operations Team as needed.
Qualifications
Required Qualifications
- Bachelor’s/Master’s degree in science.
- A Drug Safety professional with minimum 8 years of experience within drug safety and PV inclusive of safety operations.
- Advanced knowledge of ICH and pre and post market regulatory requirements.
- Advanced knowledge of ICH E2B(R2) and (R3) specifications and other safety guidance.
- Advanced knowledge of pharmacovigilance reporting rules and timelines worldwide.
- Experience with clinical and 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.
- Strong communicator and good at building professional relations to collaborators and business partners.
- Proactive and able to prioritize work in a fast paced a changing environment.
- Result- and goal-oriented and committed to contributing to the overall success of Genmab.
- Analytic, systematic, and strategic thinking.
Skills & Technologies
Go
About the Company
Genmab
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Job Details
Employment Type
Full Time
Experience Level
Executive
Location
Danmark
Posted
10 days ago
Country
DK