Director Global Patient Safety (GPS)
Job Summary
At MorphoSys, we are motivated by our mission: More life for people with cancer. As a global, commercial-stage biopharmaceutical company, we are driven by the urgency to discover, develop, and deliver groundbreaking medicines, aspiring to redefine how cancer is treated.
Our success is created by our people, and we bring together exceptional talent from around the world, offering our colleagues a collaborative, flexible, and diverse work environment. We are looking for individuals who share our values and are motivated to improve the lives of people impacted by cancer.
Since opening our U.S. office in Boston in 2019, we have doubled in size to support our rapid growth, building teams of experts across a variety of different disciplines, from drug development to commercialization.
To learn more, visit us at www.MorphoSys.com, and follow us on Twitter and LinkedIn.
Our success is created by our people, and we bring together exceptional talent from around the world, offering our colleagues a collaborative, flexible, and diverse work environment. We are looking for individuals who share our values and are motivated to improve the lives of people impacted by cancer.
Since opening our U.S. office in Boston in 2019, we have doubled in size to support our rapid growth, building teams of experts across a variety of different disciplines, from drug development to commercialization.
To learn more, visit us at www.MorphoSys.com, and follow us on Twitter and LinkedIn.
General Accountabilities
- Act as the Local Pharmacovigilance Responsible Person (LPVRP) for the US:
- Ensure implementation and effective operation of post-marketing pharmacovigilance and risk management for marketed drugs in the USA, fully integrated and compliant with the MorphoSys GPS Global PV System, maintaining strong cross-functional alignment as required
- Ensure that any clinical development safety information is incorporated as applicable for products with a BLA/NDA in the US
- Develop and implement effective pharmacovigilance and risk management for US-marketed products, in full compliance with the MorphoSys Global PV System, and all relevant PV legislation
- Serve as the MorphoSys single point of contact in the US for all matters relating to pharmacovigilance, including external with the FDA, US PV vendors
- Ensure full compliance of all aspects of the Global PV System as pertaining to products with a BLA/NDA in the US, assisted by the use of Key Performance Indicators
- Ensure all competent authority requests and interactions relevant to post-marketing drug safety and pharmacovigilance:
- As the MorphoSys single point of contact for the FDA, lead the preparation, running and follow-up of all FDA pharmacovigilance inspections and US-based PV-related audits, including tracking all CAPAs to closure and assessing the effectiveness of these;
- Ensure all Competent Authority safety-related requests, pertinent to post-marketing, for systems or drug-safety related information are answered fully and promptly
- Line management for the US-based GPS Scientist (post-marketing), ensuring delivery of all activities through effective planning, training and development
- Ensure review and accuracy of product safety information required by US Medical Affairs for inclusion in standard information response documents, FAQs for the call center as well as ad hoc responses to questions
- Active oversight of the operations of local US PV and call center vendors, in support of the global budget and contracts manager
- Ensure that the local US PV vendors are fully trained on all relevant topics, including MorphoSys products and therapy areas, and MorphoSys processes and SOPs where applicable
- Provide safety support for all post-marketing studies (PASS/PAES) to ensure full compliance with all PV obligations
- Act as the key point of contact for cross-functional colleagues, supporting their vendor management for post-marketing activities e.g. patient support programs and other organized patient data collection systems etc, ensuring compliance with all safety-relevant internal processes
- Ensure full compliance of the safety-related aspects for MorphoSys-sponsored social media
- Stay up-to-date with, and anticipate changes to, all applicable PV legislation worldwide, including maintaining expert knowledge of US REMS, PMR/PMC, and PASS development, and ensure effective communication of US-relevant regulatory intelligence for the global PV system
- Demonstrate knowledge of, and ensure compliance with company guidelines, policies and procedures and be able to demonstrate this during health authority inspections
Job Qualifications
- Professional experience in life-sciences, medicine, nursing or pharmacy (drug dispensing and usage in clinical practice); healthcare provider preferred
- Industry experience, particularly in drug safety, including post-marketing pharmacovigilance, in a global environment, and working with safety databases and vendors; 10+ years of industry experience, 8 years in drug safety
- Fluent spoken and written professional English
- Strong communication skills, oral and written – ability to present information clearly and concisely
- Strong team-working skills – working across cultural and functional boundaries
- An appropriate sense of ownership and urgency, remaining calm under pressure, demonstrating clear thinking and communication
- Skills in people management, including setting clear expectations and supporting delivery of these
- Project management skills, able to prioritize, adapt rapidly to changes in priorities, and manage multiple situations/issues, remaining calm and delivering under pressure
- •Strategic thinking
- Problem-solving and decision-making ability
- Dedication, enthusiasm, team spirit and a strong focus on quality
Full vaccination against COVID 19 is a requirement for this position.
Culture & Benefits
As a full time employee of MorphoSys US Inc., you will receive a comprehensive benefits package consisting of medical and dental, vision, life, disability and more. We offer a competitive PTO and holiday schedule – giving you the time you need to recharge, along with a 401k retirement plan which allows you the opportunity to save for your future with an employer matching program. Our culture is a collaborative work environment and we believe the unique contributions each of us brings drives our success.
EEOC Statement
MorphoSys US Inc. is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices. We are committed to creating a diverse work environment with non-discrimination for all employees and qualified applicants without regard to race, color, religion, national origin, sex, protected veteran status or disability.