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.
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.
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.
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.
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.