The Pharmacovigilance Manger will be accountable for leading the function in the advancement of Ayala’s growing portfolio. This represents a key position in Pharmacovigilance and is responsible for providing functional area day-to-day oversight and hands-on participation for programs in the clinical development setting. This cross-functional role includes active involvement on and timely contributions to clinical trails oversight of the daily PV operational aspects of safety monitoring, assurance of timely preparation and submission of individual clinical safety reports, assistance in aggregate report generation, periodic compilation and review of safety data, vendor oversight and other PV operational support, as needed.
This position requires an educational and clinical background in Health Care, preferably in oncology and specific experience in clinical trial Pharmacovigilance within a pharmaceutical/biotechnology company. Additionally, the candidate must be able to clearly communicate good PV practices and standards both in writing and verbally, including the proven ability to present complex clinical/safety scenarios in a clear, concise, logical, and medically sound manner.
The candidate must possess the ability to review information and provide timely feedback on next steps, function in a team environment, deliver on timelines and have a detailed knowledge of the activities and procedures involved in PV operations.
The PV Scientist is responsible for ensuring accuracy and completeness of clinical trial serious adverse event (SAE) reports received by vendor/vendor oversight; compilation of data for aggregate reports and signal detection; maintenance of PV inspection readiness; and compliance to regulatory reporting obligations. This individual will report to the VP RA and will be a member of the clinical team charged with making pivotal contributions to the overall safety strategy, together with Ayala’s PV consultants.
- Management of Pharmacovigilance operational activities with regard to case processing and reporting. Includes management of Contract Research Organization safety staff as appropriate to ensure that safety-related project milestones are met within required timelines.
- Collaborate with clinical and data management in the coding of adverse events, medications, and medical history in the clinical database.
- Oversee case completion to ensure relevant event information, data entry and maintenance of cases in safety database, development of safety data collection forms and tracking reports, reconciliations of serious adverse events and summarization of SAE for regulatory authorities and business partners.
- Maintain and evaluate case processing metrics including running of metric reports, creating summaries of metrics, identify any possible issues and creating an action plan.
- Preparation of data for safety review committees including, relevant cumulative listings/tables, product profile and case summaries, and analyses based upon safety review committee recommendations.
- Prepare and/or oversee the preparation, review, and finalization of aggregate reports (e.g., DSUR, IB).
- Contribute to development of standard operating procedures for safety surveillance processes.
- Provide guidance to cross-functional personnel involved in the construction of safety profiles and risk analyses and function as a PV representative at product team meetings as appropriate.
- Oversee the vendor PV quality management system including setting standards, training requirements, monitoring performance, and implementing continuous improvement activities, including metrics, key performance indicators (KPI)
- Maintain up to date knowledge with regard to current and proposed changes to domestic and international safety reporting requirements. Provides insight into operational changes required to meet current and future regulatory obligations.
- Minimum: graduate level degree in life science and at least 5 years direct patient medical care. Chronic care/oncology/internal medicine a plus
- Minimum:7 years’ experience in national and international Pharmacovigilance
- Extensive experience in the identification, validation, and implementation of clinical PV operational procedures/policies.
- Experience managing external vendors.
- Ability to manage several high-priority activities within required timelines.
- Ability to work independently with minimal supervision but seek appropriate involvement from senior management regarding complex issues within and beyond position scope.
- Solid knowledge of GVP, FDA, EMA regulations and guidelines as they pertain to PV
- Comprehensive knowledge of medical and oncology terminology, a plus