Lead the strategy, planning, execution, and maintenance of safety databases and outsourced PV activities.
Oversee collection, evaluation, and reporting of safety data from clinical trials, shaping the safety governance framework.
Manage PV vendor contracts, quality/compliance for ICSR case processing, and mentor PV operations associates.
MapLight Therapeutics is a clinical stage biotech company focused on drug discovery for central nervous system disorders. It is a growing organization that values open dialogue and mutual respect while developing novel therapies for psychiatric symptoms.
Drive global PV Operations strategy, including planning, implementation, and management, in alignment with the Head of DSPV.
Oversee vendor oversight, case management, compliance, inspection readiness, and budget/resourcing.
Represent DSPV Operations to senior leadership, manage talent, and ensure global regulatory compliance.
Vera Therapeutics is a commercial-stage biotechnology company focused on transforming medicine in autoimmune disease, starting with the kidney. Founded in 2016 and based in Brisbane, California, we foster a culture of empathy, owner's mindset, and urgency because patients are counting on us.
Lead safety review and risk management activities for assigned products.
Evaluate safety data from clinical trials, post-marketing sources, and scientific literature.
Support global regulatory submissions and health authority interactions.
Alphanumeric is a company that provides scientific and clinical safety expertise, supporting global organizations in pharmacovigilance and risk management. The company culture emphasizes independent work and collaboration across global teams.
Provide strategic medical leadership across oncology clinical programs as a trusted advisor to sponsors and teams.
Serve as Medical Monitor, overseeing patient safety, data interpretation, and safety collaborations.
Represent the organization at client meetings and conferences, mentoring medical directors and improving processes.
Precision Medicine Group is a global precision medicine-focused provider of clinical development and commercial services. The company fosters a collaborative culture centered on scientific excellence, integrity, and patient care, with a diverse international team.
Lead and supervise a team of regulatory specialists managing labeling approvals, drug listings, and medical device submissions.
Oversee FDA compliance, quality investigations, and health hazard evaluations to ensure product integrity.
Collaborate cross-functionally with Quality Assurance, Legal, and external partners to resolve complex regulatory challenges.
The partner company is a pharmaceutical and medical device organization focused on ensuring regulatory compliance and product quality. The company fosters a collaborative and inclusive work environment, emphasizing continuous improvement and professional development.
Manage end-to-end PV package preparation, quality control, and compliance tracking.
Oversee PV mailbox operations, query triage, and stakeholder communication.
Ensure inspection readiness through documentation governance and audit support.
Indegene is a technology-led healthcare solutions provider that enables healthcare organizations to be future-ready. We offer accelerated growth opportunities and a culture of entrepreneurship, innovation, collaboration, and empathy.
Support clinical development strategies and study execution across Phase 1-3 programs.
Oversee clinical safety and data review, partnering with CROs and internal teams to ensure quality.
Contribute to protocols, regulatory documents, and study reports for respiratory disease therapies.
Celea Therapeutics is a biopharmaceutical company dedicated to advancing transformative treatments for serious respiratory diseases, with its lead program in Phase 3 clinical development. As an early-stage, mission-driven team, Celea values accountability, transparency, collaboration, innovation, and passion.
Acts as the primary point of contact for trial-specific medical and safety-related questions.
Monitors trial participant safety and provides medical expertise to global clinical studies.
Reviews protocols, safety reports, and clinical study documents while supporting audits and investigator meetings.
PSI is a leading Contract Research Organization with more than 30 years of industry experience, offering a balance between stability and innovation. The company focuses on delivering quality and on-time services across therapeutic indications and is part of an international group of medical professionals.