Director, US Patient Safety
Ipsen Biopharmaceuticals Inc.
Director, United States (US) Patient Safety
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.
The US Patient Safety Director reports into the SVP, Head of US Medical Affairs. This role also has a functional reporting line into the Global Patient Safety Regional Head. He/she is an office based professional with scientific, clinical and therapeutic area understanding who is responsible for managing the local pharmacovigilance (PV) system and activities for the US. This role will act as a local qualified person for pharmacovigilance who will be a point of contact for Global Patient Safety (GPS). This role also coordinates the accurate & timely reporting and follow-up of all adverse events and special situation reports from the local territories. This role will provide the PV oversight for the Call Center vendor designee.
Ensures safety oversight of in country patient safety requirements, on all programs, identifies and can propose corrective action of any deficiencies that can impact the Ipsen PV/Medical Information (MI) System performance/ compliance, including PV/MI System structure and interfaces.
Coordinate actions if deficiencies impacting the Ipsen PV/MI System are identified and seeks to pro-actively monitor and improve systems and processes under their remit.
Interfaces and coordinates with Global Patient Safety.
Elevates the Patient Safety to a strategic pillar in the affiliate, providing insights to Therapeutic Areas and ensuring the pro-active operationalization of processes and systems.
The US Patient Safety Director will ensure local PV processes are up to date, inspection ready and ensure compliance with local regulatory requirements for drug safety. Additionally, this person will ensure local alignment with all global pharmacovigilance policies and procedures.
PV roles and Responsibilities
- Ensure US affiliate has a comprehensive local PV system with robust written procedures and PV systems in accordance with regulatory requirements
- Ensure all PV activities are delivered in line with local guidelines, legislation as well as local and global Ipsen Policies and SOPs
- Escalate safety, compliance and operational issues to GPS/ European (EU) QPPV in addition to the local Leadership.
- Perform regular review of local regulatory requirements and best practices and inform the GPS QPPV Office and/or GRA of any changes to local regulations that affect the reporting of safety data and associated reports
- Provide local reporting rules to GPS System team each time there is an update (regulation, new product etc..).
- Ensure the accurate, timely reporting to GPS and local health authority as applicable and follow-up activities of all adverse events and special situations reports and have necessary translation and quality steps in place
- Ensure review of literature for collection of AEs and Safety Signals
- Escalate any signals identified at local level or highlighted by local health authorities
- Compile monthly metric reports and perform reconciliations for adverse events (internal and with external partners)
- Provide PV oversight to the delivery of Risk Management Plans in conjunction with the cross-functional team, as applicable and ensure additional Risk Minimization Measures (aRMMs) are managed per global requirements, including local implementation and oversight of post-marketing commitments
- Provide end to end PV expertise and ensure compliant implementation for any Risk Evaluation and Mitigation Strategy (REMS) required of an Ipsen product
- Work with the quality team for product complaints so that both product complaints and adverse event reports are handled in a compliant and customer service-oriented manner.
- Work with the MI team for medical inquiries reported with safety data to ensure adverse event reports are handled in a compliant manner
- When requested, prepare and review accurate, high-quality pharmacovigilance “country” 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 country Leadership.
- Ensure compliance with PV requirements in all Company Sponsored studies (CSS), Investigator sponsor studies (ISS), Patient Data Collection Systems (i.e., Patient Support Programs, Market Research Programs, Early Access), and Digital Media conducted in the country by providing PV expertise in the review and approval of these activities
- Act as the local PV contact for all CSS, ISS, Patient Data Collect Systems (PDCS) & Digital Media conducted in the country:
- Coordinate PV activities (Safety data management including reconciliation) during the studies, programs, activities conduct till termination
- Acts as a back-up for the Ipsen Canada PV affiliate, as applicable
- Participate in out-of-hours emergency pharmacovigilance cover for adverse event reporting, as appropriate
Cross-Functional and Oversight Role
- Liaise with all functions including Commercial partners, Service Providers, third parties, and other Ipsen functions like medical affairs, regulatory affairs, medical information etc. to have an overview of processes impacting PV affiliate workflows
- Provide support to Medical Information and Product Complaint teams to ensure the receipt, management, follow up, and tracking of safety reports from all sources are forwarded to the Ipsen Global Patient Safety (GPS) for entry into the global safety database.
- Support clinical trials by reviewing study protocols to ensure inclusion of a system for timely collection and handling of safety information. Handle adverse events associated with the trials and manage collection and reporting of all safety information
- Work with the legal team to ensure that all contracts with local third parties include the appropriate PV agreement or language
- Ensure that local partners/ service providers have been qualified for PV activities
- Maintain oversight of any local/global PV agreements in the region 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.
- Collaborate with Global Regulatory Affairs to confirm specific local requirements for aggregate reports (i.e. Regional specific appendices) and to ensure compliance
- Provide information as required by or requested to support the maintenance of the EU PSMF
Training, Audit, Inspection and CAPA Management role
- Ensure that regular, documented audits of the local PV system take place
- Coordinate and input into deviations and CAPAs (Corrective Action and Preventive Action) where necessary
- Document and track deviations from PV processes and ensuring that appropriate CAPA are developed and implemented to address issues with compliance
- Perform regular review of local Quality Documents such as standard operating procedures (SOP) and work instructions to ensure that they are compliant with GVP regulatory requirements, global Quality Documents as well as local regulatory requirements as applicable
- Ensure that the PV team archiving is done in a timely fashion and in line with Ipsen SOPs and regulatory requirements
- Partnering with Training team to develop and update training programs and train new hires to PV
- Ensure that all members of the PV team maintain an up-to-date Training Record
- Ensure that pharmacovigilance training courses are provided and documented for internal and external staff such that all Ipsen affiliate staff are trained in compliance with local regulatory requirements and global/local SOPs for adverse event reporting on Ipsen products.
- Coordinate and prepare regulatory authority PV inspections and internal local office audits and support the development of responses to findings.
- Participate in inspections and audits and conducting audits as needed.
- Work with the GPS and the country Leadership to ensure a PV Business Continuity Plan is in place and tested.
- May assist in other projects, as requested by supervisor.
- Relevant degree in sciences, or experienced healthcare professional
- Advanced degree in health sciences; PharmD, Ph.D, MD is preferred
- 7+ years of experience in pharmacovigilance within the pharma industry or relevant field preferred
- 3+ years of experience in PV Operations or experience in global/regional PV roles working with affiliates in different geographies
- Experience in presenting and training on PV related subjects
- An expert working knowledge and ability to apply/interpret local Pharmacovigilance Legislation, specifically with Food and Drug Administration (FDA).
- Knowledge of clinical trial and drug approval process, clinical application of drug products
- Demonstrated expertise in drug information communication and management
- Demonstrate scientific and business expertise relevant to therapeutic areas, including products, disease state management, emerging therapies, and the competitive landscape
- Relevant therapeutic background desired (Oncology, Neurology, Rare Diseases, Endocrinology)
- Prior experience with regulatory authority inspections and internal audits including subject matter expert and end to end CAPA management
- Literature database search/review skills
Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job)
- Strong oral and written communication skills
- Ability to analyze and communicate on technical pharmacovigilance processes
- A proficient user of standard MS Office software, medical information support systems, local and global safety databases or tracking tools
- Self-motivated and organized
- Customer Focus - Is dedicated to meeting the expectations and requirements of internal and external customers
- Ability to prioritize tasks
- Strong interpersonal skills
- Strong organizational and management 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
- 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.
All Employees are expected to adhere to all company policies and act as a role model for company values.
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.