Senior Manager, Global Drug Safety & Pharmacovigilance Data Management & Analytics

Key Skills

Aartificial intelligence, Analytical and Problem solving, Data Analytics, Data management, IT, Machine learning techniques, Natural Language Processing (NLP), SQL

Job Description

The Role & Department

As a Senior Manager, Safety Data Management, you will become part of the Global Drug Safety and Pharmacovigilance (GDS&PV) department, where you will be responsible for safety data management activities including but not limited to configurations and maintenance of safety systems, generation of complex ad-hoc reports, and implementation and validation of safety systems and solutions.

Key responsibilities include

Perform accurate and timely configurations of safety systems (Argus) including but not limited to:

• Product

• Studies

• Reporting Rules

• Code lists

Generate line listings and tabulations from the safety system, using the reporting tool and/or SQL

Support to or author system related SOPs/Working Instructions.

Support during audits and inspections

Perform other safety system related activities, as needed or as requested by supervisor

Should be a good team player and efficiently work with other team members with PV

Requirements

• 5+ years of experience in the biotechnology or pharmaceutical industry with a focus on Drug Safety/Pharmacovigilance; 3+ years in safety database management

• Argus or other PV database experience is a must

• Good knowledge on clinical and post-marketing (PV) domains

• Should have good collaborative skills with the team members

• Ability to work in a fast paced environment

• Experience in writing SQL

• Good knowledge on PV related health authority regulations

• A good team member to support everyone in PV team

• Prior experience with writing/reviewing UAT/URS/Functional Specification (preferred)

• Working closely with IT to get systems/applications related activities

• Knowledge on analytical tools (like Business Objects, Spotfire etc.,) preferred

• Experience with Artificial Intelligence (AI), NLP, Machine Learning skills are preferred

The role is located in Copenhagen, DK or Utrecht, The Netherlands, or Princeton NJ, US and is a hybrid role.

For US based candidates, the proposed salary band for this position is as follows:

$114,375.00---$190,625.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to 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 leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed 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 guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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 locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.

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 https://www.genmab.com/privacy.