Director, North America Patient Safety

Cambridge, MA, United States
Oct 03, 2018
Required Education
Bachelors Degree
Position Type
Full time
Director, North America Patient Safety

Ipsen Biopharmaceuticals Inc.

Job Description:

Director, North America Patient Safety

Cambridge, MA

Company Profile

Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company, focused on innovation and specialty care. At Ipsen, we've created a workplace that recognizes and promotes an entrepreneurial spirit in our employees, and are building a strong legacy of helping patients with difficult-to-treat diseases across oncology, neurosciences and rare diseases. We know we can only be better and smarter if we work diligently together as ONE Ipsen, across all functions and geographies. We strive to break down silos and empower teams to deliver effective therapeutic solutions through highly differentiated medicines for patients with unmet needs.

We take pride in our culture, which is rooted in collaboration, to deliver results for our core customer - the patient. This level of involvement by cross-functional teams promotes a strong sense of unity, and pulls together all colleagues locally and across our key geographies, which span 115 countries across North America, Europe and Asia. As a growing organization, Ipsen North America is comprised of our Cambridge, MA, Basking Ridge, NJ and Toronto, Canada locations, with employees supporting functions including Commercial Operations, R&D, Business Development and Technical Operations.

Our employees are the driving force behind our mission at Ipsen, and to sustain their passion and focus every day, we offer a wealth of fulfilling challenges and growth opportunities through unique leadership and training programs. At Ipsen, you will work alongside industry leaders and contribute within a fast-moving and truly game-changing global organization, recognized for its talent and patient solutions. At Ipsen, we're making hope a reality for the patients we serve.

Position Summary

The North America Director of Patient Safety reports to the VP, US Regulatory Affairs and Quality. This role also had dotted line reporting into the VP Global Patient Safety. This position is an office based professional with scientific, clinical and therapeutic area understanding who is responsible for providing leadership and support for the USA and Canada Pharmacovigilance (PV) activities. This role also coordinates the accurate & timely reporting and follow-up of all adverse events and special situation reports from the local territories.

The Patient Safety Director will ensure compliance with FDA and Health Canada Regulatory requirements for drug safety. Additionally, this person will ensure local alignment with all global pharmacovigilance policies and procedures. This role will provide oversight for the Safety Call Center vendor designee.

Essential Functions

  • Supports the business through the provision of drug safety expertise in the review and approval of activities such as Patient Support Programs and Patient Data Collection Systems
  • Ensures that Ipsen USA and Canada has a comprehensive local PV system
  • Acts as a back-up for the Ipsen Canada PV affiliate, as applicable
  • Ensures all PV activities are delivered in line with local guidelines, legislation as well as local and global Ipsen Policies and SOPs
  • Ensures that regular, documented audits of the local PV system take place
  • Coordinates and input into deviations and CAPAs (Corrective Action and Preventive Action) where necessary
  • Performs the regular review of local SOPs and Instructions to ensure that they are compliant with GVP regulatory requirements and global SOPs
  • Ensures that the PV team archiving is done in a timely fashion and in line with Ipsen SOPs and regulatory requirements
  • Provides oversight to Call Center Staff to ensure the receipt, management, follow up, and tracking of safety reports from all sources are forwarded to the Ipsen Global Patient Safety (GPS) Case Processing Center for entry into the global safety database.
  • Ensures the accurate, timely reporting and follow-up activities of all adverse events and special situations reports
  • Provides Pharmacovigilance oversight to the delivery of Risk Management Plans in conjunction with the cross-functional team, as applicable
  • Compiles monthly metric reports and perform weekly/monthly reconciliations for adverse events and product quality complaints (internal and with external vendors)
  • Provide Pharmacovigilance expertise in to all areas of the business as required.
  • When requested, prepares and reviews accurate, high quality pharmacovigilance reports (aggregate safety reports and other ad hoc reports) and documentation, within agreed regulatory timelines, to assist in meeting local regulatory requirements, as required under the supervision of GPS, and/or US Leadership.
  • Acts as the PV contact for all Ipsen sponsored local clinical trials
  • Ensures that appropriate PV language is included in local contracts with vendors, as appropriate.
  • Work with the legal team to ensure that all contracts with external vendors include the appropriate PV agreement or details
  • Works with the quality manager for product complaints so that both product complaints and adverse event reports are handled in a compliant and customer service-oriented manner.
  • Documents and track deviations from PV processes and ensuring that appropriate CAPA are developed and implemented to address issues with compliance
  • Maintains oversight of any local/global PV agreements in the US and collaborate in the review of such agreements as required. Maintain direct relationship with the third-party partner and be responsible for oversight of the implementation and maintenance of the safety exchange with the partner, including monitoring compliance.
  • Ensures that pharmacovigilance training courses are provided and documented for internal and external staff such that all US based Ipsen staff are trained in compliance with local regulatory requirements and global/local SOPs for adverse event reporting on Ipsen products.
  • Acts as the local contact for all Patient Data Collect Systems (PDCS):
    • Provides training and support with regards to PDCS's to Ipsen colleagues
    • Assesses program for eligibility and liaise with the Global PDCS Officer
  • Ensures all documentation is completed, PV training is provided, and that the Global Inventory is updated
  • Acts as the local PV contact for Global Patient Safety (GPS)
  • Acts as the PV contact for all Ipsen sponsored local clinical trials
  • Participates in out-of-hours emergency pharmacovigilance cover for adverse event reporting, as appropriate.
  • Performs regular review of local regulatory requirements and best practices and inform the QPPV Office and/or GRA of any changes to local regulations that affect the reporting of safety data and associated reports to the FDA and as appropriate, Health Canada.
  • Supports and attend affiliate/GPS meetings to ensure awareness of any changes in global and/or regional requirements of the PV system
    • Escalate safety, compliance and operational issues to GPS in addition to the US Leadership.
    • Provide local reporting rules and review that they are appropriately set up in the global safety database.
  • Collaborates with Global Regulatory Affairs to confirm specific local requirements for aggregate reports (ie. Regional specific appendices) and to ensure compliance
  • Coordinating and preparing for regulatory authority PV inspections and internal affiliate country office audits and supporting the development of responses to findings.
  • Providing information as required by or requested to support the maintenance of the PSMF
  • Work with the GPS and the US Leadership to ensure a business continuity plan is in place and tested annually.
  • May assist in other projects, as requested by supervisor.


  • Bachelor's Degree
  • Medical science or healthcare degree preferred (e.g. nursing, pharmacy, or medical degree)

  • 8+ years of Pharmacovigilance Experience in a Pharmaceutical Industry or related Clinical Pharmacy Practice/Managed Care Experience Required
  • Experience in presenting and training on PV related subjects
  • A working knowledge and ability to apply/interpret local Pharmacovigilance Legislation both FDA and Health Canada guidelines.
  • Relevant therapeutic background desired (Oncology, Neurology, Rare Diseases, Endocrinology)

Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job)

  • Possessing good oral and written communication skills
  • Ability to analyze and communicate on technical pharmacovigilance processes
  • A proficient user of standard MS Office software and of medical information support systems
  • Self-motivated and organized
  • Proficient in MS office applications.
  • Customer Focus - Is dedicated to meeting the expectations and requirements of internal and external customers
  • Ability to prioritize tasks
  • Strong verbal communication skills
  • Ability to work independently and as a team player
  • Be result-oriented, proven track record of success
  • Must Demonstrate flexibility in response to changing needs and competing demands.
  • Must Demonstrate a positive attitude.
  • Solutions oriented.
  • Travel up to 10% (may include international travel to Global Team meetings)

    The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

    Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

    Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.

    IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.