Director, Pharmacovigilance Operations

About the role  

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas.  As the Director, Pharmacovigilance Operations you will report to the Head of PV and Safety and be involved in all related operational activities of product safety surveillance and ensure the safety of product development. The Director, Pharmacovigilance Operations encompasses a key leadership role in providing direction to the Pharmacovigilance department.  This role will include support for development of the safety/PV department, support and management of internal and external PV stakeholders, development and oversight of PV CRO functions and compliance for the SMP (safety management plan), adverse event case management, aggregate report development and submissions, SOP, WI’s, document guidance and form development, support of the signal detection/risk management of safety data for clinical trials and post marketing (where applicable), CAPA and quality oversight, support of audits and inspections and partner management (when applicable).

Cool stuff!

What you’ll do  

• Responsible for performing critical safety vendor oversight to ensure all pharmacovigilance activities are performed in an efficient, consistent and compliant manner.
• Management of external shareholders, license partners and vendors. Development and implementation of pharmacovigilance agreements (PVAs) and Safety Data Exchange Agreements (SDEAs) as well as monitoring compliance to the mentioned PVAs and SDEAs.
• Accountable for coordination of day-to-day operational ICSR activities in collaboration with designated management personnel at the vendor site(s).
• Provide oversight and review of vendor case processing and submission activities
• Review and monitoring of CRO compliance through various monitoring reports and other oversight activities such as tracking of KPIs, metrics and QC of SAE / ICSR cases in Safety database
• Manage SAE / SUSAR reporting activities for all investigational drugs (Maintain oversight to ensure Global clinical trials case reporting process is efficient and compliant with reporting requirements) and post marketing cases when applicable
• Oversee maintenance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events
• Provide direct technical /data management support to ensure information entered and retrieved from the safety database is consistent, accurate and complete in accordance with data requests.
• Manage SAE reconciliation process with internal and external partners
• Assist in development, review and approval of search strategies for literature review
• Contribute and support safety monitoring and signal detection activities for products including overseeing report scheduling and deliverables for signal identification, evaluation, interpretation of safety signals and prioritizing signals for full evaluation and communication of safety risks.
• Support PSRT (program safety review team) quarterly and ad hoc analyses meetings including recording and approval of minutes.
• Ensure Global clinical trials case reporting process is efficient and compliant with reporting requirements detailed in the safety management plans (SMP) / PV agreements
• Support the oversight and management of global business partner safety data exchange agreements/ pharmacovigilance agreements and other contracts as applicable to ensure compliance with data exchange activity. Communicates with partner companies and vendors regarding processing and timely exchange of safety data.
• Oversees distribution of aggregate reports as required and assists with reconciliation activities if needed.
• Develop and maintain Safety and Pharmacovigilance related documents including CRO Safety Management Plans, SOPs and Work Instructions, ESRP (PV expedited and periodic safety reporting plan) and Safety Data Exchange Agreements.
• Provide guidance and support to project teams for safety-related areas, including protocol development and study conduct
• Contribute to preparation of relevant safety sections of clinical study reports, annual reports, expedited safety reports and other regulatory filing documents
• Assist as needed with the preparation and updates to Investigator Brochures, DSURs, Protocols, ICFs, IBs (including RSI determination), CSRs, CCDS, RMP, REMS etc.
• Assist with response to safety-related queries from regulatory authorities or Ethics Committees, if needed
• Support the development of PV infrastructure, including new safety projects and set-up of safety systems applicable to safety data from the medical and scientific perspective
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