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.
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.
Resolves assignments from Board, President, SDMD Head and Director of ICSR Line.
Ensures effective Line Management in assigned teams (up to 15 direct reports/line manager spread globally).
Supports Team leads with deviation management and Business Development and Proposals with any existing and new opportunities.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They offer services within Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. They value employee experience, well-being and mental health.
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.
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.
Works with the Director of Quality Assurance to drive excellence and optimize audit and Inspection hosting.
Drives ongoing quality improvement measures through communication of audit results and compliance guidance/training.
Manages the audit and inspection hosting team.
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.
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.
Support Safety Physicians with safety-related tasks across commercial products and products in clinical development.
Contribute to safety risk management including but not limited to routine review of safety data and pertinent scientific literature articles.
Conduct signal detection activities and analyses of safety data to support appropriate benefit-risk assessment as directed by the Safety Physician.
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. The company was founded to develop a better way to treat the cellular drivers of tumor growth.
Develop and report key quality metrics across all clinical programs and trials.
Ensure compliance with GCP, ICH-GCP, FDA, EMA, PMDA, and applicable regulations.
Drive inspection readiness at local and global levels.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business.