Director, Global Drug Safety & Pharmacovigilance Physician

12+ years

$170,625.00---$284,375.00

Princeton Junction

12 May 17, 2024

Job Description

Job Type: Full Time Education: MD Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Director, GDS&PV Physician

Company: Genmab

Location: Flexible; includes Copenhagen, Denmark; Utrecht, the Netherlands; Princeton, New Jersey, USA; and Tokyo, Japan.

Employment Type: Full-time

Salary Range: $170,625.00 - $284,375.00 (For US-based candidates)

About the Company: Genmab is an international biotechnology company dedicated to improving the lives of patients through innovative antibody therapeutics. With a robust pipeline and strategic partnerships, Genmab is focused on pioneering cancer treatments and addressing serious diseases. Established in 1999, Genmab has offices in Copenhagen, Utrecht, Princeton, and Tokyo.

Job Summary: The Director, GDS&PV Physician will lead major safety-related activities and ensure the global safety strategy for Genmab products, primarily investigational. This role involves cross-functional collaboration, regulatory compliance, and mentoring junior colleagues.

Key Responsibilities:

Lead pre- and post-marketing safety activities, including signal and risk management.
Collaborate with cross-functional teams for safety assessment and communication.
Oversee safety issue handling and risk mitigation.
Provide inputs for trial protocols, clinical trial reports, and related documents.
Prepare regulatory documentation, including safety summaries.
Manage forums like Data Monitoring Committees and Safety Committees.
Train and mentor team members on safety and PV processes.
Engage with internal and external stakeholders regarding safety and regulatory issues.
Support the Clinical Research Department with case processing.
Participate in training and inspections related to PV processes.

Qualifications:

MD required.
Minimum 12+ years in drug safety/pharmacovigilance, preferably in oncology.
Experience with PV audits and regulatory authority inspections.
Knowledge of global PV regulations, MedDRA, WHODrug coding, and safety databases (ARISg, ARGUS).
Proven leadership and mentoring skills.
Strong analytical and communication skills.

Skills:

Proficient in safety databases and electronic data capture systems.
Ability to manage multiple projects and deadlines.
Excellent written and verbal communication.
Strong team collaboration and mentoring capabilities.

Work Environment: Genmab offers an agile working environment with a balance of remote and in-office work. The offices are designed as open, community-based spaces to foster collaboration and innovation.

Diversity Commitment: Genmab is committed to diversity, equity, and inclusion. All applicants will be considered without regard to race, color, religion, sex, national origin, age, disability, or genetic information.

Application Process: Please visit Genmab Careers to apply and review our privacy policy for handling your data.

Additional Information:

For positions in the Netherlands, initial employment contracts are fixed-term for one year, with potential renewal for an indefinite term based on performance and business conditions.
Benefits include medical, dental, vision, and 401k.

About You:

Passionate about transforming patient lives through innovative treatments.
Rigorous and excellence-driven in problem-solving.
Collaborative team player with diverse backgrounds.
Determined to achieve and enable the best work.
Innovative and adaptable in a dynamic company.
Enjoys working hard and having fun.

Join Genmab: If you are ready to be part of a groundbreaking team at the intersection of healthcare and technology, apply now and help us revolutionize cancer treatment and serious disease therapies.

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Director, Global Drug Safety & Pharmacovigilance Physician

Job Description

Job Title: Director, GDS&PV Physician

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