- 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
- Responsible for SOP development and facilitation of training, including training GVP Modules and key relevant US & EMA safety-related Guidance documents and procedures
- Oversee deviation and CAPA activities in relation to, but not limited to, late SUSAR or aggregate report submissions as well as deviations relating to case management processes as defined per the SMPs or SOPs
- Serve as member of PV QA team with support for external and internal audits and inspections
- BSN, PharmD or similar related scientific background
- 10+ years of directly related experience in Pharmacovigilance
- Experience working with and overseeing vendors and partners
- Proven history of successful interaction with internal and external stakeholders
- Experienced in pre- and post-approval pharmacovigilance activities, including safety reporting
- Experience completing successful PV data migrations is a plus
- Strong proficiency in verbal and written communication; great attention to detail, ability to meet project deadlines
- Ability to work independently, to manage work priorities, to build collaborative team relationships at all levels and remain flexible to the needs of the teams / projects. Must be able to work on multiple projects simultaneously
- Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
- Experience with safety database systems (ARGUS, Aris G)
- Proficient in standard computer software (Word, Excel and Power point presentations)
- The base pay range for this position at commencement of employment is expected to be between $210,000 to $240,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
- Lead from every seat - we seek to understand, act with honesty, and engage in the crucial conversations
- Thrive as a team - we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
- Make it happen - we value vigorous debate, alignment around our decisions, and resilient execution
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Description
Job DetailsAbout 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
At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.
Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana's Benefits Portal .
We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.
To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.
