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.
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.
Author aggregate safety reports including PBRER, PSUR, DSUR, and others for submissions to health authorities.
Coordinate with stakeholders to obtain data, plan timelines, and ensure timely delivery of reports.
Mentor junior team members, conduct training, and maintain awareness of regulatory guidelines.
ClinChoice partners with pharmaceutical, medical device, and consumer care companies to accelerate clinical trials and ensure product safety. With a global delivery network spanning multiple countries, they provide expertise in clinical operations, biometrics, pharmacovigilance, and more.
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.
Manage the intake, review, analysis, and reporting of Individual Case Safety Reports (ICSRs) and support Clinical Events Committees and Data Monitoring Committees.
Co-author and maintain study-specific safety documents and prepare aggregate safety reports for regulatory submission.
Collaborate with sponsors, study teams, and cross-functional partners to ensure data quality and compliance with GCP and GVP standards.
This partner company delivers high-quality safety services across clinical research and medical device programs. They foster a collaborative, detail-oriented environment with a focus on compliance and patient outcomes.
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.
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.
Provide frontline virtual or telephonic support to clients and healthcare professionals.
Document and report Information Requests, Adverse Events, and Product Quality Complaints.
Ensure compliance with FDA regulations, HIPAA, and company policies.
Inizio is a pharmaceutical services company providing medical information and patient support. They are a large organization committed to building a diverse, inclusive workforce and fostering a culture of leadership and collaboration.
Provide virtual or telephonic medical information support to customers, patients, and healthcare professionals.
Ensure compliance with FDA regulations, pharmacovigilance requirements, and company procedures.
Document and escalate information requests, adverse events, and product quality complaints accurately.
Inizio Engage is a pharmaceutical services provider that delivers medical information, patient support, and pharmacovigilance solutions. The company fosters a diverse, inclusive culture with a focus on compliance and quality.