Ipsen Pharma
Associate Director, US Patient Safety
Ipsen Pharma, Cambridge, Massachusetts, us, 02140
Title:Associate Director, US Patient Safety
Company:Ipsen Biopharmaceuticals Inc.
Job Description:
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
Main responsibilities / job expectations
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 systemEscalate 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 reportsManage the local PV service provider to ensure the accurate, timely reporting to GPS and Health authority as applicableContribute 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 applicableParticipates 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.Knowledge, abilities & experience
Education / Certifications:
Relevant degree in sciences, or experienced healthcare professionalAdvanced degree in health sciences; PharmD, Ph.D, MD is preferredExperience:
5-7 years of experience in pharmacovigilance within the pharma industry or relevant field preferred3+ years of experience in PV Operations or experience in global/regional PV roles working with affiliates in different geographiesExperience in presenting and training on PV related subjectsAn expert working knowledge and ability to apply/interpret local Pharmacovigilance Legislation, specifically with Food and Drug Administration (FDA) and all applicable post-marketing requirementsKnowledge of clinical trial and drug approval process, clinical application of drug productsDemonstrated expertise in drug information communication and managementDemonstrate scientific and business expertise relevant to therapeutic areas, including products, disease state management, emerging therapies, and the competitive landscapeRelevant 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 managementLiterature database search/review skillsKey Technical Competencies Required
Strong oral and written communication skillsAbility to analyze and communicate on technical pharmacovigilance processesA proficient user of standard MS Office software, medical information support systems, local and global safety databases or tracking toolsCustomer Focus - Is dedicated to meeting the expectations and requirements of internal and external customersStrong interpersonal, organizational, and management skillsAbility to work independently and as a team playerBe result-oriented, proven track record of successMust demonstrate flexibility in response to changing needs and competing demandsTravel up to 10% (may include international travel to Global Team meetings)
The annual base salary range for this position is $143,250 - $210,100.
This job is eligible to participate in our short-term incentives program.
At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.
The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.
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.
Company:Ipsen Biopharmaceuticals Inc.
Job Description:
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
Main responsibilities / job expectations
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 systemEscalate 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 reportsManage the local PV service provider to ensure the accurate, timely reporting to GPS and Health authority as applicableContribute 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 applicableParticipates 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.Knowledge, abilities & experience
Education / Certifications:
Relevant degree in sciences, or experienced healthcare professionalAdvanced degree in health sciences; PharmD, Ph.D, MD is preferredExperience:
5-7 years of experience in pharmacovigilance within the pharma industry or relevant field preferred3+ years of experience in PV Operations or experience in global/regional PV roles working with affiliates in different geographiesExperience in presenting and training on PV related subjectsAn expert working knowledge and ability to apply/interpret local Pharmacovigilance Legislation, specifically with Food and Drug Administration (FDA) and all applicable post-marketing requirementsKnowledge of clinical trial and drug approval process, clinical application of drug productsDemonstrated expertise in drug information communication and managementDemonstrate scientific and business expertise relevant to therapeutic areas, including products, disease state management, emerging therapies, and the competitive landscapeRelevant 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 managementLiterature database search/review skillsKey Technical Competencies Required
Strong oral and written communication skillsAbility to analyze and communicate on technical pharmacovigilance processesA proficient user of standard MS Office software, medical information support systems, local and global safety databases or tracking toolsCustomer Focus - Is dedicated to meeting the expectations and requirements of internal and external customersStrong interpersonal, organizational, and management skillsAbility to work independently and as a team playerBe result-oriented, proven track record of successMust demonstrate flexibility in response to changing needs and competing demandsTravel up to 10% (may include international travel to Global Team meetings)
The annual base salary range for this position is $143,250 - $210,100.
This job is eligible to participate in our short-term incentives program.
At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.
The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.
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.