Senior Manager, Global Drug Safety & Pharmacovigilance, Safety Operations
Senior Manager, Global Drug Safety & Pharmacovigilance, Safety Operations
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
At Genmab we are dedicated to building extranotordinary 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:
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.
- Bachelors/Masters 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!
Locations
Genmab maximizes the efficiency of an agile working environment when possible for the betterment of employee work-life balance. Our offices are crafted as open community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.
About Genmab
Genmab 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 Genmabs 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 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 Job Applicant Privacy Notice ().
Required Experience:
Exec
Employment Type
Full-Time
