At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit? Then we would love to have you join us!
The role
As an Associate Director Safety Operations, you will become part of the Global Drug Safety and Pharmacovigilance department, where you will become responsible for safety operations including but not limited to collection of safety information from various sources, quality control of safety data entry, compliance of individual case safety reports to regulatory authorities and business partners, and reconciliation of safety information between the clinical and the safety database as well as between Genmab and partners.
Key Responsibilities:
- 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.
- Perform regular trending and analysis of quality data and compliance metrics to identify potential issues and propose long-term strategies for quality improvement or issue resolution.
- Oversee the review of study-specific documents and the set-up/ maintenance of study-specific activities ensuring consistency across studies.
- Proactively identify opportunities for improvement in study document templates and/or in study set-up and maintenance processes.
- Responsible and accountable for the timely documentation, monitoring and closure of all owned Quality Events (Deviation, Change Control and/or Corrective Actions/Preventive Actions (CAPAs)).
- Oversee or develop/ 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.
- Guides and supports direct reports in achieving their goals and fosters a positive work environment specifically overseeing the progress of the team, resolving conflicts and ensuring that employees feel valued and motivated in their roles.
- Other activities, as needed or as requested by supervisor.
Requirements- 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.
The proposed gross annual base salary range for this position, in the primary location, based on a full time schedule is:
DKK700.000,00---1.050.000,00
The final salary offer will depend on several factors, including your skills, qualifications, and experience.
In addition to base salary, this position is eligible to additional forms of compensation, such as discretionary bonuses and long-term incentives.
When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to:
- Pension
- Health insurance and wellness benefits
- Paid time off
- Employee support programs
Further details on compensation and benefits will be provided during the recruitment process.
About GenmabGenmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on
LinkedIn and
X.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website
Responsibilities
- 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.
- Perform regular trending and analysis of quality data and compliance metrics to identify potential issues and propose long-term strategies for quality improvement or issue resolution.
- Oversee the review of study-specific documents and the set-up/ maintenance of study-specific activities ensuring consistency across studies.
- Proactively identify opportunities for improvement in study document templates and/or in study set-up and maintenance processes.
- Responsible and accountable for the timely documentation, monitoring and closure of all owned Quality Events (Deviation, Change Control and/or Corrective Actions/Preventive Actions (CAPAs)).
- Oversee or develop/ 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.
- Guides and supports direct reports in achieving their goals and fosters a positive work environment specifically overseeing the progress of the team, resolving conflicts and ensuring that employees feel valued and motivated in their roles.
- Other activities, as needed or as requested by supervisor.
- 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.
