Associate Director, US Patient Safety

at  Ipsen Biopharmaceuticals Inc

KNOWLEDGE, ABILITIES & EXPERIENCE

Education / Certifications:

• Relevant degree in sciences, or experienced healthcare professional
• Advanced degree in health sciences; PharmD, Ph.D, MD is preferred

Experience:

• 5-7 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) and all applicable post-marketing requirements
• 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

SUMMARY / PURPOSE OF THE POSITION

The US Patient Safety Associate Director reports into the Senior Director, US Medical Information and Patient Safety. This role also has a functional reporting line into the Global Patient Safety (GPS) Regional Head. The role 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 the US PV subject matter expert to coordinate the accurate & timely reporting and follow-up of all adverse events and special situation reports from the local territory.
In addition, this role is responsible for the proactive monitoring and continuous improvement of the local PV systems and processes under their remit. This role will also manage the PV oversight for the outsourced activities involving pharmacovigilance.
The US Patient Safety Associate Director will maintain local PV processes that are current, inspection ready, and compliant with local regulatory requirements for drug safety. Additionally, this person will ensure local alignment with all global pharmacovigilance policies and procedures with a focus on proactive and continuous improvement

RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING:

• Contribute in and attend affiliate/GPS meetings to ensure awareness of any changes in global and/or regional requirements of the Ipsen PV system
• Escalate safety, compliance and operational issues to local Leadership and GPS/ QPPV.
• 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
• Manage the local PV service provider to ensure the accurate, timely reporting to GPS and Health authority as applicable
• Contribute to monthly metric reports and ensure reconciliations for adverse events (internal and with external partners) are performed.
• Provide Pharmacovigilance 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 and local requirements.
• When requested, coordinate accurate, high-quality local 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 Local Leadership and GPS.
• Provide PV expertise and oversight to ensure compliance with PV requirements in all Company Sponsored studies (CSS), Investigator sponsor studies (ISS), Patient Data Collection Systems (ie Patient Support Programs, Market Research Programs, Early Access), and Digital Media conducted in the country.
• Coordinate PV activities (Safety data management including reconciliation) during the studies, programs, activities conduct till closure.
• Acts as a back-up for the Ipsen Canada PV affiliate, as applicable
• Participates in out-of-hours emergency pharmacovigilance cover for adverse event reporting, as appropriate.

CROSS-FUNCTIONAL & 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, contribute to the safety monitoring plans per global procedures.
• Handle adverse events associated with the clinical trials and manage collection and reporting of all safety information.
• 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 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 Pharmacovigilance System Master File (PSMF).

TRAINING, AUDIT, INSPECTION AND CAPA MANAGEMENT ROLE

• Coordinate and manage deviations and CAPAs (Corrective Action and Preventive Action) where necessary.
• Perform regular review of local Quality Documents (QDs) to ensure that they are compliant with GVP regulatory requirements, global QDs and local regulatory needs, as applicable.
• Ensure that the PV team archiving is done in a timely fashion and in line with Ipsen QDs and regulatory requirements.
• Lead the updates of the local pharmacovigilance training courses tailored to the audience and ensure appropriate training documentation in compliance with local regulatory requirements and global/local SOPs for adverse event reporting on Ipsen products.
• Coordinate, prepare, and participate in regulatory authority PV inspections and internal local office audits and supporting the development of responses to findings, as needed.
• Work with Local Leadership and GPS to ensure a PV Business Continuity Plan is in place and tested.
• May assist in other projects, as requested by supervisor.