Provide advanced scientific oversight of ICSR and clinical trial SAE evaluation, ensuring medical accuracy, regulatory reportability, and consistency across global development programs.
Drive ongoing safety surveillance activities by analyzing aggregate safety data, identifying emerging safety signals, and contributing to risk–benefit assessments for investigational and marketed products.
Collaborate with clinical development, clinical operations, regulatory, medical writing, and quality partners to provide scientific leadership on safety topics and ensure alignment on safety strategy and interpretation.
Centessa Pharmaceuticals is a pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Their asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity.
Ensure oversight for assigned product pharmacovigilance activities.
Manage pharmacovigilance aggregate reports and stakeholder input to meet regulatory timelines.
Conduct safety surveillance and signal detection activities.
EyePoint is committed to preventing blindness by developing and commercializing innovative therapeutics. They operate with a science-based entrepreneurial culture. They value the trust of patients, employees, and the community.
Conduct scientific review and evaluation of ICSRs and clinical trial SAEs.
Perform ongoing safety surveillance through analysis of adverse event data.
Support preparation, review, and scientific input into safety deliverables.
Centessa Pharmaceuticals is a new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. They are advancing a portfolio of high conviction programs with strong biological validation and their asset-centric model offers a unique R&D logic.
Oversee end-to-end ICSR collection, processing, reconciliation, and reporting of post-marketing cases.
Ensure global compliance with pharmacovigilance regulations, including timely ICSR submission, high-quality case processing, and support for aggregate reporting.
Provide oversight and support of the PV vendor activities, including but not limited to the establishment and monitoring key performance indicators (KPIs) and vendor audits.
Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. They were founded to develop a better way to treat the cellular drivers of tumor growth and committed to fair and equitable compensation practices.
Act as Local Contact Person for Pharmacovigilance for the designated country.
Develop strategy and manage set up activities.
Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They value employee experience, well-being and mental health, acknowledging that a healthy work life balance is a critical factor for employee satisfaction.
Assist in design, author and/or review clinical study synopses, protocols, study reports and other study-related documents.
Act as a medical monitor for assigned study and discuss study design with investigators and key opinion leaders.
Track emerging efficacy and safety profile of drugs in clinical trials; inform Clinical Development team of changes in the efficacy/safety profiles.
Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for cancer patients. The company aims to improve cancer treatment by targeting cellular drivers of tumor growth and is publicly traded.