Senior Manager, Pharmacovigilance (PV) Operations
Harpoon Therapeutics (ticker: HARP) is a clinical-stage immunotherapy company developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. T cell engagers are engineered proteins that direct a patient’s own T cells to kill target cells that express specific proteins, or antigens, carried by the target cells. Using its proprietary Tri-specific T cell Activating Construct (TriTAC®) platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. HPN424 targets PSMA and is in a Phase 1/2a trial for metastatic castration-resistant prostate cancer. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. HPN217 targets BCMA and is in a Phase 1/2 trial for relapsed, refractory multiple myeloma. HPN328 targets DLL3 and is in a Phase 1/2 trial for cancers expressing DLL3, initially focused on small cell lung cancer and other tumors with high-grade neuroendocrine features. Harpoon is led by an experienced management team. The company emphasizes a collegial, collaborative environment and has a strong record of scientific innovation, pioneering protein engineering, expertise in tumor immunology and pre-clinical and clinical research. For additional information about Harpoon Therapeutics, please visit www.harpoontx.com.
SUMMARY: The Senior Manager, PV Operations is responsible for ensuring efficient and compliant processes are in place to allow timely collection and reporting of safety data. This includes oversight of Case Management, Drug Safety Systems, Alliance and Vendor Management, and Submissions Compliance.
The Senior manager, PV Operations will act as a liaison with internal departments and external business partners on PV operational issues and clinical study related activities, e.g., represent PV on study teams, support SAE reconciliation, and develop safety management plans and other clinical study reporting forms.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Ensure effective processes are in place related to global adverse event case processing to allow for high quality safety reports to be submitted to global recipients within required timelines.
- Act as a liaison with internal departments and external business partners on PV operational issues and clinical study related activities
- Develop, review, and update drug safety forms and templates and harmonization with relevant clinical operation forms and templates (i.e., SAE data collection form and eCRF)
- May contribute to drug safety documents, including but not limited to SAE reporting plan covering study-specific SAE workflow, IND and EU annual reports and other periodic reports
- Member of study management team for assigned study protocols
- Oversee case processing vendor in processing adverse event information and assists in the preparation of internal and external reports
- Manage and Review SAE reconciliation between clinical and safety databases
- Assist with data-lock SAE reconciliations and ensure all safety cases are complete and all outstanding queries are resolved and closed
- Manage the preparation of safety-related sections and associated documentation for clinical and regulatory documents (i.e. clinical study protocols and IBs)
- Contribute to aggregate safety reports including Developmental Safety Update Report (DSUR) or IND Annual report and other periodic safety line listings as required
- Accountable for identification, initiation, development and implementation of PV process improvements, tools, systems and procedures to enable excellence and consistency in PV activities in collaboration with other stakeholders
- Responsible for the oversight, management and communication for all future global business partner safety data exchange agreements and other contracts as applicable and ensure compliance with data exchange activity
- Participate in vendor and technology evaluation, qualification and selection. Supports RFP development and contract review, as needed. Identifies and implements solutions to global PV issues and concerns
- Cultivate effective and productive working relationships with colleagues, vendors and management. Uses clear judgment to solve problems and to escalate issues with proposed solutions, as necessary
- Responsible for ensuring compliance with SOPs and global regulations, GCP, ICH guidelines and Good Clinical Practices internally and by vendors via regular process auditing.
- Participate in SOP development, training, process mapping, and other departmental activities
- Ensure PV activities and procedures are in an inspection-ready state
- Participate in regulatory inspections and internal audits to ensure the quality, integrity and compliance with safety reporting requirements, including authoring of relevant responses to findings
- Requires a health care professional background, either nurse or PharmD and minimum of 5 years of practical clinical and/or clinical safety experience, or
- BS/BA degree in a health related or biological science related field and 6+ years of practical clinical and/or clinical safety experience, or
- Equivalent combination of education and experience
- A thorough understanding of the global PV regulatory environment with working knowledge of EU and US regulations, ICH guidelines, and GCP, a working understanding of drug safety databases, effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective
- Experience with Global Drug Safety database is required and MedDRA knowledge utilizing WHO- Drug dictionaries for coding consistency and knowledge of safety reporting regulations and guidance
- Previous experience in a small-company environment and collaborating/communicating with partner companies a plus
- Several years previous experience in PV vendor oversight
- Proficiency with MS Word, Outlook, and PowerPoint Experience in core PV activities (e.g., Safety Management plans)
- Excellent interpersonal, organizational, influence management and communication (oral and written) skills
- Ability to work effectively in both a team setting and independently with minimal oversight
- Demonstrated ability in logical thinking, attention to detail and accuracy, good organizational skills, and problem-solving abilities
- Ability to prioritize and to adapt quickly to changing business conditions with a positive attitude