Director, Pharmacovigilance Safety Evaluation
SF Bay Area
A late-stage Rare Disease & Oncology company is looking for a Director, PV Safety Evaluation to join its team in this newly created role. This organization submitted its first BLA in 2020 for a therapy that treats Pediatric Growth Hormone Deficiency. This company has 5 other indication in its pipeline ranging from Pre-Clinical to Phase 3 of development. You will also receive equity in this position and given the company expects to commercialize its first product in Q3 2021 it can be an incredibly lucrative time to join. If interested in learning more don't hesitate to apply!
The Director, Pharmacovigilance Safety Evaluation will be responsible for:
- Assists Sr Director, PV for drug safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements and for signal detection, evaluation and risk management.
- Supports Pharmacovigilance Department direction, standards, and processes for supporting Corporate safety monitoring activities.
- Assists Sr Director PV Safety Evaluation and QPPV in activities for monitoring patient safety, e.g., adverse event reports for potential safety related issues and provides recommendations when potential issues are identified.
- Supports to ensures that all safety reports received from any source are reviewed according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures.
- Performs Quality Control reviews of assigned cases to ensure the accuracy, integrity, medical reviews and completeness of information entered in the safety database as needed.
- Liaises with Medical Monitors in Clinical Development to ensure that appropriate medical review and assessment is provided for adverse event reports received and non-clinical safety findings reported.
- Liaises with Medical Monitors in the analysis, identification and reporting or possible trends and concerns regarding 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.
- Assists in the development of safety surveillance and risk management plans for drug development programs.
- Supports the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report, etc.).
- Leads the negotiation of safety data exchange/pharmacovigilance agreements 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.
- Assists in the preparation and revision of company product labeling as appropriate.
- Assists in the preparation and review of safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other.
- Collaborates with, and provides pharmacovigilance guidance and support for interdepartmental and/or corporate initiatives
- Ensures awareness and training of appropriate Company personnel and external groups of PV and Drug Safety principles, policies and SOPs.
- 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.
- Supports preparation and maintenance of departmental policies and SOPs that address the processing, analysis and reporting of safety information to ensure proactive surveillance of products in development.
- Through coordination with GCP and PV Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits.
- Functions as a PV advisor to Clinical Development Organizations, Medical Affairs, Commercial Organizations and PV staff.
- Provides pharmacovigilance expertise to or CRO/Vendor staff when needed.
- Ensuring SP/vendor oversight under the guidance of Sr Director, PV Safety Evaluation and QPPV by developing and implementing SP Oversight plans as required by PV SOPs.
- In case of safety queries received from local Regulatory Authorities, under the direction of Sr Director, Pharmacovigilance Safety Evaluation inform relevant local and global personnel and respond in a timely manner to ensure tracking of the responses.
- Participate in relevant crisis management activities within the scope of PV group.
- Works closely with Sr Director, PV Safety Evaluation and EU QPPV to be aware of all safety issues/concerns and provide consultation when needed
Ideal Candidates will have:
- MD, PHD, or RN with significant experience.
- Signal detection, management, and tracking experience.
- Experience with RMP (Risk Management Planning) activities
- Oncology experience