Pyros Pharmaceuticals
PV Operations Specialist
Pyros Pharmaceuticals, Trenton, New Jersey, United States,
Remote (ET or CT time zones)
Company Overview
Pyros is a specialty pharmaceutical company focused on developing and commercializing innovative medicines for rare diseases with unmet needs. With an initial focus on Infantile Spasms (IS) - a rare and sometimes life-threatening form of pediatric epilepsy - we recognize the significant emotional burden this condition imposes on families. Pyros is working to offer an enhanced treatment option for families affected by IS and other rare diseases.
Role Summary
The
PV Operations Specialist , reporting to the Senior PV Operations Specialist, will be responsible for assisting in the overall quality and compliance of PV operations. This includes global literature surveillance, adverse event (AE) and special situation (SS) event case processing, management of the case workflow, submission of individual case safety reports (ICSRs), assisting in review and authoring of PV SOPs, and PV vendor oversight.
ResponsibilitiesEnsure PV compliance with global regulatory and competent health authority requirements by oversight of all case processing activities.Knowledge of ICSR and Aggregate reporting to FDA; experience in successfully meeting all ICSR reporting requirements.Perform prospective QC of cases and ensure metrics and service level agreements (SLAs) are met per safety data exchange agreement (SDEA) contracts.Have working knowledge of Risk Evaluation and Mitigation Strategies (REMS).Reconcile ICSRs with omnichannel intake methods and manage ICSR triage and workflow routing.Support risk benefit analysis, aggregate reporting, and signal detection by performing QC of queries from the global safety database.Assist in documenting literature surveillance and triaging of pertinent medical literature associated with risk benefit analysis of all Pyros products.Assist in operational support and meeting minutes for the Drug Safety Review Board (DSRB).Understand and assist in implementation of best practices for coding of AE terms to MedDRA and the impact of MedDRA upgrades.Review and/or writing of work instructions, conventions, and SOPs as needed.Assist in computer systems validation (CSV) for upgrades/changes to the global safety database, including user acceptance testing (UAT).Possible call intake and outbound follow-up attempts with postmarketing reporters.Preparing for audit and inspection readiness.Maintain proficiency in global drug safety regulations as it pertains to Pyros products.Support the growth of an in-house PV Operations Team.Other duties as assigned.Skills & RequirementsExperience with end-to-end ICSR and aggregate report processing, including ICSR processing within Oracle Argus Safety of spontaneous, solicited (e.g. – specialty pharmacy), and literature cases.Perform oversight of follow-up queries.AE case intake, triage (including duplicate case checks), processing, and assessment (e.g. – event listedness, event seriousness, etc.).Experience in PV Operations; either in a Pharmaceutical or CRO environment.Knowledge of best practices for PV and compliance with FDA and global regulatory agencies.Experience in working with a PV Operations group to facilitate on-time case processing and assisting in implementing remedial actions, if needed.Mentoring others in PV Operations.Compilation of meeting minutes, metrics, and SLAs.Collaborating with multiple PV vendors/suppliers to ensure contractual and regulatory authority PV obligations are met.Understanding of the nuances of complicated patient histories (e.g. - concomitant medications) and comorbid disease states on the therapeutic outcome of the patient.Postmarketing experience is preferred.ICSR submission experience to FDA is preferred.Call center AE and SS intake and/or follow-up is preferred.Veeva Vault Safety database experience is preferred.Excellent interpersonal skills, communication skills, and written communication.QualificationsBS in nursing, pharmacy, or other healthcare degree. RN is preferred.3+ years performing clinical safety and/or postmarketing case processing within a global safety database within PV Operations.Physical DemandsOccasionally mobile within home office environment.Routinely in a stationary position for extended periods of time.Constantly operating a computer, telephone, and other similar office machinery.BenefitsCompetitive salary and benefits package.Medical, dental, vision (most tiers are fully compensated by Pyros).HSA and FSA.Life and supplemental life insurance.401(k) with company match.Generous PTO with rollover.Generous holidays.
Pyros is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.
Privacy PolicyLegal Notices
#J-18808-Ljbffr
Company Overview
Pyros is a specialty pharmaceutical company focused on developing and commercializing innovative medicines for rare diseases with unmet needs. With an initial focus on Infantile Spasms (IS) - a rare and sometimes life-threatening form of pediatric epilepsy - we recognize the significant emotional burden this condition imposes on families. Pyros is working to offer an enhanced treatment option for families affected by IS and other rare diseases.
Role Summary
The
PV Operations Specialist , reporting to the Senior PV Operations Specialist, will be responsible for assisting in the overall quality and compliance of PV operations. This includes global literature surveillance, adverse event (AE) and special situation (SS) event case processing, management of the case workflow, submission of individual case safety reports (ICSRs), assisting in review and authoring of PV SOPs, and PV vendor oversight.
ResponsibilitiesEnsure PV compliance with global regulatory and competent health authority requirements by oversight of all case processing activities.Knowledge of ICSR and Aggregate reporting to FDA; experience in successfully meeting all ICSR reporting requirements.Perform prospective QC of cases and ensure metrics and service level agreements (SLAs) are met per safety data exchange agreement (SDEA) contracts.Have working knowledge of Risk Evaluation and Mitigation Strategies (REMS).Reconcile ICSRs with omnichannel intake methods and manage ICSR triage and workflow routing.Support risk benefit analysis, aggregate reporting, and signal detection by performing QC of queries from the global safety database.Assist in documenting literature surveillance and triaging of pertinent medical literature associated with risk benefit analysis of all Pyros products.Assist in operational support and meeting minutes for the Drug Safety Review Board (DSRB).Understand and assist in implementation of best practices for coding of AE terms to MedDRA and the impact of MedDRA upgrades.Review and/or writing of work instructions, conventions, and SOPs as needed.Assist in computer systems validation (CSV) for upgrades/changes to the global safety database, including user acceptance testing (UAT).Possible call intake and outbound follow-up attempts with postmarketing reporters.Preparing for audit and inspection readiness.Maintain proficiency in global drug safety regulations as it pertains to Pyros products.Support the growth of an in-house PV Operations Team.Other duties as assigned.Skills & RequirementsExperience with end-to-end ICSR and aggregate report processing, including ICSR processing within Oracle Argus Safety of spontaneous, solicited (e.g. – specialty pharmacy), and literature cases.Perform oversight of follow-up queries.AE case intake, triage (including duplicate case checks), processing, and assessment (e.g. – event listedness, event seriousness, etc.).Experience in PV Operations; either in a Pharmaceutical or CRO environment.Knowledge of best practices for PV and compliance with FDA and global regulatory agencies.Experience in working with a PV Operations group to facilitate on-time case processing and assisting in implementing remedial actions, if needed.Mentoring others in PV Operations.Compilation of meeting minutes, metrics, and SLAs.Collaborating with multiple PV vendors/suppliers to ensure contractual and regulatory authority PV obligations are met.Understanding of the nuances of complicated patient histories (e.g. - concomitant medications) and comorbid disease states on the therapeutic outcome of the patient.Postmarketing experience is preferred.ICSR submission experience to FDA is preferred.Call center AE and SS intake and/or follow-up is preferred.Veeva Vault Safety database experience is preferred.Excellent interpersonal skills, communication skills, and written communication.QualificationsBS in nursing, pharmacy, or other healthcare degree. RN is preferred.3+ years performing clinical safety and/or postmarketing case processing within a global safety database within PV Operations.Physical DemandsOccasionally mobile within home office environment.Routinely in a stationary position for extended periods of time.Constantly operating a computer, telephone, and other similar office machinery.BenefitsCompetitive salary and benefits package.Medical, dental, vision (most tiers are fully compensated by Pyros).HSA and FSA.Life and supplemental life insurance.401(k) with company match.Generous PTO with rollover.Generous holidays.
Pyros is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.
Privacy PolicyLegal Notices
#J-18808-Ljbffr