ADC Therapeutics

Director, Pharmacovigilance Scientist

ADC Therapeutics

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Lead

About the role

  • Develops and maintains an understanding of the safety profile of their assigned product(s)
  • Supports product safety surveillance activities for assigned product(s) during all phases of the product life cycle
  • Leads Safety Scientist activities of cross-functional project teams for developmental compounds and/or marketed products.
  • Responsible for individual and aggregate case reporting activities including ICSR case management and aggregate reporting.
  • Works in collaboration with the Sr Medical Director to develop, maintain, oversee, and execute comprehensive safety surveillance.
  • Conduct signal detection, (including adverse event data, literature, and other sources) in collaboration with Sr Medical Director and according to ADCT’s Signal Management and Safety Governance process, and management activities including but not limited to maintenance of signal tracker, authoring safety topic reviews for signals or issues including PQC or in response to Regulatory Authority requests.
  • Author and contribute safety sections and other relevant content to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports, safety management plans.
  • Participate in and provide input for iDMC or internal monitoring committee meetings as applicable
  • Leads the collaboration with Sr Medical Director and Clinical representatives and authors the Reference Safety Information (RSI) for assigned products.
  • Authors/provides strategic input or oversight for periodic regulatory documents (PBRERs, PSURs, DSURs) according to processes and timelines.
  • Authors/provide strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the Sr Medical Director and other functional experts.
  • Contributes to pharmacovigilance and risk management planning and activities for ADCT products, including preparation and maintenance of CCDS, labeling documents Risk Management Plans with the applicable License Partners as appropriate, REMS if applicable and risk communications
  • Supports multidisciplinary SMT/JSMT and escalation of all relevant safety matters to the appropriate decision-making level, providing appropriate proposals for solutions based on analysis of the available information and in collaboration with the Sr Medical Director.
  • Take on the responsibility for appropriate specialized roles within PV. This may include but not limited to: o Provide vigilance expertise on operational processes to stakeholders o Work in close collaboration with QA to ensure up-to-date processes and procedures for operational activities in the end-to-end safety process, including ICSR process, aggregate reports, Safety agreement, Safety Regulatory report processes. o Establish, negotiate, implement and maintain safety agreements (SDEA, PVAs, SMPs) o Provide vendor oversight and achieve defined performance metrics for patient safety operations process. o Ensure Patient Safety (including Safety Operations) function is inspection ready, assisting PV function and quality personnel during inspections and audits o Drive PS performance standards towards quality, inbound and outbound compliance o Establish and implement best practice sharing in PV activities

Requirements

  • Bachelor’s in sciences/pharmacy/nursing degree or related field however RN, R.Ph., or Pharm D. degree is highly preferred.
  • 10+ years of proven pharmacovigilance experience, preferably in oncology
  • Patient Safety and/or Clinical/Drug Development with proven experience working in safety &/or scientific activities in at least 3 of the following areas: - Clinical drug development (Early and/or Late Phase: develop & deliver program level safety strategy, including proactive risk identification & mitigation planning) - Post-Marketing Surveillance (including signal detection & evaluation) - MAA/BLA (preparation and authoring of the safety related aspects of the Common Technical Document) - Periodic Safety Reports (deliver strategy, preparation and authoring) - Risk Management Plans (deliver strategy, preparation and authoring) - Safety governance board interactions and communication across a range of activities
  • Demonstrated ability to handle more than one activity simultaneously, prioritizing and recognizing key issues
  • Ability to work effectively in an advanced matrix structure
  • Proficient in expressive and receptive communications in English language
  • Experience authoring safety signal assessment report, DSUR, PBRER, RMP, and RSI
  • Skilled in signal detection process and managing safety information from clinical development and post-marketing sources
  • Experienced with FDA/EMA regulations and ICH guidance governing pharmacovigilance and risk management
  • Knowledge of drug development process, pharmacovigilance databases and MedDRA coding
  • Experience with use of safety databases, preferably Argus Safety Database
  • Documented experience in multiple trials with safety inputs at the Global level
  • International experience from a similar role with internal and external stakeholders
  • Participate in audit preparedness activities and serves as subject matter expert during regulatory inspections in collaboration with team members.