Sr. Manager, Pharmacovigilance
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, and mesothelioma. 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.
The Pharmacovigilance Sr. Manager is responsible for ensuring efficient and compliant processes are in place to allow timely collection and reporting of patient safety data. The Pharmacovigilance Sr. Manager will act as a liaison with internal departments and external business partners on pharmacovigilance (PV) operational issues and clinical study related activities, such as: represent Drug Safety/PV on study management teams, oversee case processing activities, draft/review safety/clinical related documents as required.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Oversee case processing activities, ensuring ICSRs are of high quality, completed and adhered to the agreed processing timelines in order to support timely submissions/distributions 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.
- Contribute to the draft/review/update of drug safety related forms, documents and templates (i.e., SAE data collection form, Safety management plans, SAE reporting plans, aggregate/periodic safety reports, etc.).
- Contribute to the draft/review/update of safety sections of study protocols, Investigator’s Brochure, Inform Consent Forms, etc.
- Support signal detection and risk management activities.
- Represent PV in study management teams for assigned studies.
- Manage SAE reconciliation activities between clinical and safety databases.
- Assist with data-lock activities, ensuring that all cases in the Safety database are complete and all outstanding queries are resolved and closed.
- Support the development and implementation of PV process improvements, tools, systems and procedures to enable excellence and consistency in PV activities in collaboration with other stakeholders.
- Support the oversight, management and compliance of business partner Safety data exchange agreements and other contracts as applicable.
- Participate in vendor and technology evaluation, qualification and selection.
- Cultivate effective and productive working relationships with colleagues, vendors and management. Uses clear judgment to solve problems and escalate issues with proposed solutions, as necessary.
- Ensure compliance with SOPs and global regulations, GCP, ICH guidelines and Good Clinical Practices internally and by vendors.
- Participate in SOP development, training, process mapping, and other departmental activities.
- Ensure PV activities and procedures are in an inspection-ready state.
- May support Health Authority inspections and internal audits to ensure the quality, integrity and compliance with safety reporting requirements, including authoring of relevant responses to findings.
- Any other tasks assigned by manager to assist in departmental activities.
- Health care professional background (Nursing, Pharmacy, Medicine or equivalent), or
- BS/BA degree in a health related or biological science related field, or
- Equivalent combination of education and experience
- Minimum of 6 years of experience in Drug Safety/Pharmacovigilance, or equivalent experience in pharma/biotech is required
- 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 Drug Safety databases, as well as MedDRA and WHO DD knowledge are required
- Previous experience in a small-company environment and collaborating/communicating with partner companies a plus
- Proficiency with MS Word, Outlook, PowerPoint, and other computer programs
- Excellent interpersonal, organizational, 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