Provide strategic leadership and functional representation for complex projects, ensuring effective coordination and execution of regulatory tasks.
Act as a franchise liaison between Ergomed Plc and clients, assisting in securing new business by participating in bid defenses and contributing to proposals and budgets.
Offer expert regulatory guidance, training, and mentoring to junior staff, while driving department initiatives and managing change implementation.
PrimeVigilance is a global pharmacovigilance specialist that helps clients navigate complex regulations while keeping patient safety at the center of every decision. With a presence across Europe, North America, South America, Asia, and Australia, the company fosters a culture built on kindness, flexibility, growth, and belonging.
Serve as primary contact for project-related matters, managing client expectations to ensure satisfaction with PrimeVigilance services.
Prepare project scope and objectives based on signed agreements, and plan activities including deadlines and interim milestones.
Report to clients and PrimeVigilance management, including monthly reports for invoicing basis.
PrimeVigilance is a global pharmacovigilance specialist helping clients navigate complex regulations while keeping patient safety at the center of every decision. The company operates across Europe, North America, South America, Asia, and Australia, fostering a culture built on kindness, flexibility, growth, and belonging.
Lead global pharmacovigilance strategy and safety governance.
Ensure compliance with FDA, EMA, ICH, and GCP standards.
Build and lead a high-performing pharmacovigilance organization.
Deciphera is a biopharmaceutical company focused on developing kinase inhibitors for cancer. The company fosters a culture of scientific excellence, accountability, and patient-focused decision making.
Lead global pharmacovigilance operations for clinical trials and post-marketing safety.
Ensure regulatory compliance with FDA, ICH, and GVP standards across international markets.
Build and mentor high-performing teams while driving business development and financial performance.
The company is a fast-growing clinical research organization specializing in pharmacovigilance and drug safety. It emphasizes operational excellence, regulatory compliance, and patient safety, with a global reach and a collaborative culture.
Monitor and evaluate telephone and electronic interactions for adverse events, product quality complaints, and medical information requests to ensure compliance with regulatory and client standards.
Identify quality and performance trends and partner with leadership to provide coaching, feedback, and training for continuous improvement.
Compile and report QA metrics, support internal and client audits, and maintain confidentiality of sensitive information.
Inizio Engage is a healthcare services company specializing in medical information, pharmacovigilance, and patient support programs. The company is part of a global organization and is committed to providing equal employment opportunities and fostering a diverse and inclusive workplace.
Leads the timely and accurate submission of data calls and statistical data to regulatory authorities.
Reviews and interprets regulatory reporting requirements and analyzes their impact.
Provides technical advice, training, and mentorship to internal teams and external partners.
Sutton National Group is a rapidly growing national property and casualty insurance carrier group. They foster a collaborative, fast-paced environment and are an equal opportunity employer.
Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.
Provide leadership and mentorship across regional clinical trials while ensuring high-quality study execution with minimal travel.
Oversee monitoring visit reports, manage study risks, and ensure compliance with corrective measures at country and regional levels.
Collaborate with cross-functional teams, lead project calls, and deliver training to support data integrity and site performance.
PSI CRO is a privately owned, global Contract Research Organization dedicated to advancing medical science and bringing new therapies to patients worldwide. Founded in 1995, the company has over 3,000 employees and prides itself on long-term stability, having never undergone a merger, acquisition, or company-wide layoffs.
Oversee outsourced Medical Information Contact Center vendor, managing performance, governance, and compliance for medical inquiries, adverse event intake, and product quality complaints.
Partner with internal teams to integrate contact center workflows with Medical Affairs, Pharmacovigilance, and IT systems, ensuring seamless data transfer and regulatory adherence.
Ensure all operations are inspection-ready, maintain procedural documents, and deliver performance reporting to leadership.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. The company is headquartered in Radnor, Pennsylvania, and operates as a fully remote organization with a collaborative culture.
Manage day-to-day regulatory affairs support, including clinical trial applications and compliance with global regulations.
Provide expert guidance to project stakeholders, ensuring timely and high-quality service delivery.
Develop regulatory strategies and tools, staying current with industry best practices and regulatory changes.
Alimentiv provides global regulatory affairs support services for clinical research. The company emphasizes high-quality service delivery, compliance with industry standards, and a collaborative culture.