Head of Pharmacovigilance Operations

Location: London or homebased, UK

Reporting to: VP Global Head of Pharmacovigilance

Orchard Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically modified blood stem cells and seeks to correct the underlying cause of disease in a single administration.

Job summary

Leads Pharmacovigilance Operations (PV Ops) including but not limited:

• Case processing: all activities related to the case processing from clinical trials to post-marketing for events reported to Orchard PV (or PV vendor/service provider)

• Regulatory ICSR submissions from clinical trials and post-marketing sources
• Oversight of PV Ops activities /services provided by outsourced PV Service Provider(s)/vendor(s) (CROs)
• Oversight of safety set up, management and closure activities for Orchard sponsored clinical trials (e.g. safety management plans, safety reporting forms, templates, reconciliation, etc.) and non-Orchard sponsored clinical trials where Orchard PV Ops has been contracted to provide the PV service or where Orchard PV Ops oversee the third party PV vendor/service provider
• Post-marketing safety data collection set-up and management (e.g. PASS, call center material, training and training material, safety database set up)
• Orchard Safety database system owner
• Oversee Orchard drug safety inbox monitoring and management
• Support the set up and management of Safety Data Exchange Agreements (SDEAs)/Pharmacovigilance Agreements (PVAs) and oversee execution of safety exchange and reconciliation activities
• Prepare Orchard PV Ops SOPs and WIs and provide support and review Orchard Signal Risk Management and Orchard Compliance and QPPV office SOPs and WIs
• Participate in relevant meetings e.g. clinical trial/study team meetings, PV vendor meetings, new study KOMs, SIVs as required
• Line management of Orchard PV specialists/associates supporting PV Ops

Key Elements and Responsibilities

Orchard safety database:

• System owner
• Safety database access management and training oversight for all Orchard PV personnel and all the relevant PV vendor/service prover personnel
• Data entry guidelines and conventions
• MedDRA and Who-DD dictionary updates in the Orchard safety database, case processing and safety submissions of ICSRs/SUSARs from clinical trials and post-marketing as per regulatory requirements and timelines
• Safety report generation e.g. signal detection, CSR, interim analyses and DSMP
• EudraVigilance registrations
• Responsible person for Orchard sponsored clinical trials
• Oversight of Orchard training and training material regarding safety reporting e.g. study investigators and site monitors [Orchard sponsored studies], PV vendor personnel, Orchard PV personnel, QTC training, product manual and call centers
• Support and participate as Orchard PV Ops representative (incl. readiness activities)
• Represent PV Ops at the trial/study meetings
• Study start up, maintenance and closure activities related to PV Ops incl. Safety Management Plans and safety reporting forms for Orchard sponsored clinical trials (e.g. SAE reporting form, pregnancy reporting form), SAE reconciliation, monthly status reports, case reporting and expedited reporting to regulatory authorities, independent ethics committees/independent review boards and investigator sites
• Support clinical study protocol development and review process
• Oversight of Orchard Drug Safety mailbox management and monitoring (e.g. SAEs, literature reports, spontaneous reports, complains received, social media outcomes)
• Execute safety exchange and reconciliation with business partners as per the relevant SDEA/PVA
• Ensure Orchard PV Ops related SOPs and WIs are developed and reviewed appropriately
• May support management and negotiation of PV agreements
• Performance/line management of Orchard PV Ops personnel
• Liaise with other Orchard departments and functions and provide PV Ops support and expertise

Requirements

Required knowledge

• Extensive years of relevant experience in the Pharmaceutical or Biotech industry working in Pharmacovigilance, Drug Safety or a related field. Previous experience in gene therapy is preferred
• Must have significant experience in case processing, quality review and expedited reporting
• Excellent experience in clinical trial safety support e.g. safety management plans, SAE reconciliation, compliance management
• Excellent understanding of safety database functionalities e.g. Argus, ARISg. Previous experience as a safety database system owner is a plus
• Must have an in-depth understanding of FDA, EMA and other Health Agency regulations regarding pharmacovigilance activities
• Previous managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
• Strong experience in PV vendor management incl. vendor selection, budget review, change order management and conflict management
• Essential to be an effective team member and strong leader in a cross-functional department
• Strong communication and influencing skills
• Strategic and innovative thinking with strong analytical skills
• Proven track record in capability building in Drug Safety, Risk Management / PV functions
• Proficient in prioritising assignments and able to adapt to rapidly changing priorities.
• Extensive experience in monitoring of operational safety issues, and solution-oriented approach to crisis issues under pressure.
• Demonstrated ability to identify process improvement
• Conflict management

Skills & Abilities

Education

• Degree educated in relevant field (e.g. BSc, RN/RGN, MPharm), Master level degree preferred