Director/Senior Director, Pharmacovigilance & Risk Management
Remote with travel -- West Coast Based
Rapidly growing biopharmaceutical company, is seeking a highly motivated and experienced individual to lead our Risk Management & Pharmacovigilance team.
Reporting to the CMO, the Director/Senior Director of Pharmacovigilance & Risk Management (Director/Sr. Director of PV & RM) ensures all safety functions are performed in a timely, accurate, compliant, and informed manner to support all the company's products. Safety functions have applicable, privacy laws, product liability, and risk management components. The Director/Sr. Director of PV & RM will work closely with the Clinical Development team, Regulatory team, and other relevant functional groups in assessing and addressing safety issues. The Director/Sr. Director of PV & RM will also be responsible for coordinating all drug safety-related activities with corporate partners and PV vendors.
As the first in-house PV hire, this individual will be joining a small but highly motivated and specialized Clinical Development team to support multiple clinical programs in global development. Hands on experience with global clinical trial conduct and PV vendor management is required.
- Partner with the clinical development team to lead the oversight of safety monitoring of products and author/present signal evaluation reports for review at safety committee.
- Medical and regulatory evaluation of Serious Adverse Events and issues management
- Oversee quality, medical accuracy and completeness of individual case files that are subject to global regulatory audit and retained for the life of the product. Additionally, oversee adverse event investigations and bring to a timely conclusion.
- Ensure Regulatory compliance of initial safety submissions and follow-up submissions to US and Global Regulatory agencies.
- Create and chair a multidisciplinary safety committee, which reviews select individual serious adverse event cases and aggregate adverse event data for trends, as well as signal detection summaries from all studies. The multidisciplinary safety committee will also be responsible for decision-making framework and timelines for any safety related updates relevant to regulatory documents (e.g., Investigator Brochure, Informed Consent Forms, Dear Healthcare Provider Letters etc.)
- Prepare cumulative reports with analysis of events received for the reporting period for submission to FDA and global regulatory agencies. Review statements made in external communications safety for accuracy.
- Author or approve safety sections of Clinical Study Reports, other clinical documents (IB or protocol), Development Annual Safety Reports (DSUR) and/Integrated Safety Summaries (ISS) in marketing authorization applications in accordance with ICH Guidelines and regional regulatory requirements.
- Oversee and support the PV vendor to ensure the integrity of the safety database is maintained for all products (may participate in database reconciliations).
- Facilitate and coordinate Independent Data Monitoring Committees alongside the clinical development team, if applicable. Prepare presentations, maintain communication as specified in the charters, and promptly respond to issues.
- Lead development of departmental SOPs to include safety monitoring procedures to assure company oversight of safety decision-making/governance in compliance with regional regulatory requirements in the context of outsourced PV vendor model.
- Lead/support PV-related activities associated with new asset acquisition and/or divestiture (e.g., safety data migration, due diligence activities).
- Provide on-call support for safety emergencies.
- MD preferred or advanced health related sciences degree (PharmD, ARNP or PAC); or equivalent
- Proven track record of industry pharmacovigilance experience. (8-10+ years applicable experience)
- Prior experience with therapeutic biologics is required
- Therapeutic area experience in oncology and/or virology is highly desired
- Experience with developing, implementing, and measuring the impact of pharmacovigilance processes and systems across multiple projects
- Strong project management skills & experience
- Expertise in regulatory requirements and guidelines pertaining to drug safety and risk management
- Strong written and oral communication skills
- Proven record of being able to coordinate and drive timelines for regulatory safety documents
- Ability to interpret, communicate, and present clinical, scientific, and medical information in a clear and concise manner
- Demonstrated ability to proactively and effectively influence peers and external colleagues across all levels of management
- Proven excellence in operational strategy
- Prior experience leading and/or building teams is highly preferred
- Prior experience with global marketing applications (NDA/BLA/MAA) and new product launch and PV experience in lifecycle management phase of development program is a plus
- Possession of a working style that is goal-driven, results-oriented, and committed to high quality
- Demonstrated ability to: develop/maintain strong working relationships with cross-functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently
- Proven ability to effectively collaborate with internal team and external collaborators.
- This position may require up to 10% domestic travel and limited international travel (little travel is anticipated during the COVID-19 pandemic)