Manager/Senior Manager/Associate Director – Drug Safety/PV Operations
This position offers a candidate the opportunity to take on a key leadership role in providing direction to the Drug Safety department for adverse event case management, support of study teams and projects, oversight of maintenance of drug safety database, and collaboration to support risk management and pharmacovigilance for all B Therapeutics Clinical Trials and post-marketing (where applicable).
- Responsible for performing critical safety vendor oversight to ensure all pharmacovigilance activities are performed in an efficient, consistent and compliant manner.
- Accountable for coordination of day-to-day operational ICSR activities in collaboration with designated management personnel at the vendor site(s).
- Responsible for facilitation of training and development of vendor personnel (remotely and on-site at the vendor site) as required, driving the development of self-sufficiency at the vendor.
- Manage Vendor Oversight including tracking of KPIs, metrics and QC of SAE/ICSR cases in Safety database.
- Lead B Therapeutics Safety Operations in ensuring all safety reports received from all clinical trials are processed in a consistent and a fully compliant manner. 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).
- Oversee maintenance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events from B Therapeutics clinical trials.
- Ensure Global clinical trials case reporting process is efficient and compliant with reporting requirements detailed in the safety management plans (SMP)/ PV agreements and safety data exchange agreements.
- Review incoming adverse events to determine action required
- Overall accountability of partnership collaboration on the exchange of safety data, safety monitoring, and the safety profile of investigational drugs as defined in Pharmacovigilance Agreements
- Lead preparation of safety-related plans with partners and CROs
- 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, etc.
- Lead Staff PV training and external CRO's on drug safety principles and procedures, including training GVP Modules and key relevant US & EMA safety-related Guidance documents and procedures
- Assist with response to safety-related queries from regulatory authorities or Ethics Committees, if needed
- Collaborate to ensure alignment among case handling, aggregate reporting, and signal detection activities
- Support the development and review of appropriate safety sections of key product documents including: IBs (including RSI determination), study protocols, ICF, CSRs, CCDS, RMP, REMS
- Assist with the ongoing review TFLs and AE data from ongoing studies to evaluate common AEs, lab abnormalities, and summarize the results in the product safety reports
- Conduct safety data review and analysis, summarize safety data in support of regulatory submission activities, signal detection and management activities, or in response to ad hoc safety inquiries from health authorities, track all safety related activities
- Support projects or other initiatives from cross functional groups and departments (Clinical Development, Regulatory Affairs, Quality and Toxicity), ensure adequate safety support and timely update of safety information to drug safety physicians
- Supports the development of B Therapeutics Drug Safety infrastructure, including new safety projects and set-up of safety systems applicable to safety data from the medical and scientific perspective
- 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
- Participate in regulatory inspections and PV audits to ensure the quality, integrity and compliance with pharmacovigilance and safety reporting requirements
- Education: Master in life sciences, PharmD, RPh, Ph.D., RN, PA
- Experience: minimum 5-year experience in pharmacovigilance in a pharmaceutical or biotechnology company.
- Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines)
- Experienced in pre- and post-approval pharmacovigilance activities, including safety reporting, signal detection activities (safety data analysis, categorization, assessment).
- Solid clinical knowledge and strong analytical ability to review, evaluate, interpret, and synthesize clinical and safety data.
- 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