The Head of Safety Science encompasses a key role in setting and executing departmental strategy and in managing the day-to-day functioning of the Drug Safety & PV department. This role collaborates with colleagues and vendors representing Clinical Science, Clinical Operations, Biometrics, Regulatory & QA and Legal. The incumbent will be the inaugural member of the Safety function at Revance and establish the infrastructure and key processes required to enable successful development of the company's aesthetic and therapeutic programs, thereby having significant influence on shaping the future of the Company.
Additionally, the role will have primary accountability for the role of Safety Lead across and will oversee the Safety deliverables for Revance's lead product, DaxibotulinumtoxinA for injection, including the development and execution of the long-range safety strategic plans for the molecule, including the design, monitoring, analysis, and reporting of studies and other data sources throughout the product lifecycle. The successful candidate will also bring safety expertise to the company's interactions with Health Authorities and Data Monitoring Committees and represent the Company at scientific meetings. They will perform as a hands-on leader who is both collaborative, a self-starter, and who has the ability to work in a matrixed environment.
Leads the establishment of the Safety Function to effectively manage PV within a small company as part of an evolving process from a pre-market, US-only setting, to post-commercial globalization.
Responds to the evolving regulatory environment with an emphasis on PV and drug safety, including REMS, PMCs, post-marketing surveillance and reporting of identified adverse reactions.
Ensures that all safety reports received from any source are processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures
Performs Quality Control reviews of all cases to ensure the accuracy, integrity and completeness of information entered in the safety database
Ensures that expedited and non-expedited safety reports are submitted to regulatory authorities and partner companies as appropriate
Liaises with Medical Monitors in Clinical Development to ensure that appropriate medical review and assessment is provided for assigned case reports
Leads bi-weekly clinical data review in collaboration with Clinical Development, Data Management and Clinical Programming
Manages communications with CROs regarding the evaluation and processing of case reports
Oversees the set-up of new safety projects, including development of study-specific Safety Management Plans and set-up of safety systems
Assists Medical Director(s) in the analysis, identification and reporting or possible trends and concerns regarding Revance products, and key competitive products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety
Manages the planning and preparation of the adverse events section of protocols and informed consents for clinical studies
Participates in the negotiation of safety exchange agreements (PVAs) with license partners and distributors in support of process definition, monitoring and other roles as required by drug safety to perform the drug safety mission
Participates in the development and management of Data Monitoring Committees, including development of DMC Charters and QA/QC of required line-listings and aggregate summaries of applicable safety data DB
Ensures that the applicable safety DB data with external groups such as the DM staff for clinical studies; Drug Safety personnel from partner companies, etc. is governed by Revance SOPs
Oversees the preparation of ASURS, DSURs, IND Annual Reports, PSURs/PBRERs and other global periodic safety reports
Participates in the development and review of appropriate safety sections of IBs, CSRs, ISS, NDAs
Manages the process for identifying, evaluating, and selecting outsourcing vendors (CROs, Call Centers, safety DB vendors)
Ensures awareness and training of appropriate Company personnel and external groups of PV and Drug Safety principles, policies and SOPs
Reviews aggregate safety data from the clinical DB in support of Data Monitoring Committee meetings, interim analyses or final DB lock
Monitors industry best practices, changes in global safety regulations and guidelines for marketed and investigational projects and recommends changes and upgrades to existing departmental policies, SOPs and systems
Prepares and maintains departmental policies and SOPs that address the processing, analysis and reporting of safety information to ensure proactive surveillance of products in development
Participates in the development and management of departmental budget
Understanding of GxP and regulated processes and end-to-end clinical trial lifecycle
Direct management responsibility over the safety function for a minimum of 5 years
Demonstrated experience in industry setting for at least 10 years