Sr. Manager/Associate Director Global Patient Safety (GPS) Operations

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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.

General Accountabilities

  • Responsible for maintaining the MorphoSys Global Pharmacovigilance System, to ensure that all standards, processes and Quality Documents are current with relevant PV legislation worldwide
  • Act as back up for the US-Local Pharmacovigilance Responsible Person (LPVRP), assuring audit and inspection readiness especially for but not limited to US related audits / inspections
  • Serve as second line MorphoSys point of contact in the US for all matters relating to pharmacovigilance, including external communications with the FDA, US PV vendors, etc. 
  • Stay up-to-date with, and anticipate changes in, applicable PV legislation worldwide with strong focus on FDA requirements
  • Ensure inspection-readiness regarding the compliance of the MorphoSys PV System with all applicable PV legislations worldwide
  • Manage US-based PV audits and inspections in strong collaboration with Quality Assurance and support PV audits and inspections globally
  • Plan and manage delivery of all new, and amendments to existing, Quality Documents and related tools (templates, checklists etc.) that impact the PV System, so that they are implemented according to timelines
  • Maintain the MorphoSys Pharmacovigilance System Masterfile (PSMF) 
  • Implement and manage a process for maintenance of the MorphoSys PSMF so that, if required, it can be provided within 7 calendar days’ notice
  • Manage the process for GPS Mailboxes 
  • Implement and manage a process for management of the GPS Mailboxes, so that all messages are acted upon appropriately; ensure that this role is delegated effectively in times of absence
  • Ensure effective process for relevant training for all MorphoSys staff
  • Manage the coordination of GPS activities in relation to pharmacovigilance inspections and audits, including Partner Company inspections and audits, so that all required process documentation is provided, and subject matter experts are available and prepared
  • Manage US-based PV inspections ensuring local logistical arrangements and support
  • Ensure that appropriate training materials are provided to support the implementation of all new and amended Quality Documents, and that training is delivered efficiently to all relevant MorphoSys staff
  • Ensure that processes are in place for delivery and tracking the delivery of general PV training for all MorphoSys staff
  • As a core member of the GPS PV System Concordance Committee, provide assurance on the inspection-readiness of the PV System

Job Qualifications

  • University degree in a relevant academic field in a life-science, nursing, pharmacy or medicine; advanced degree preferred
  • 5+ years of industry experience in drug safety, working in a global environment with sound knowledge of industry and pharmacovigilance legislation for clinical trial and post-marketing settings. 
  • Professional experience in healthcare or bioscience, which may include clinical practice or academia
  • Fluent spoken and written professional English
  • Excellent communication skills, oral and written – ability to present information clearly and concisely
  • Strong team-working skills – working across cultural and functional boundaries
  • 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
Health & Safety
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.