Jobs at Ergomed

Conducts pre-study, initiation, interim, and close-out monitoring visits for Phase 2/3 clinical trials. Assesses investigator sites, staff, facilities, equipment, and resources; trains site personnel; supports regulatory and ethics committee submissions; and ensures study quality and compliance. The role requires extensive on-site monitoring experience, preferably in complex oncology or rare disease trials, strong communication and organizational skills, and national travel.

Conducts on-site and remote monitoring visits for Phase 2/3 clinical trials, including pre-study, initiation, interim, and close-out activities. Verifies investigator qualifications, site resources, facilities, equipment, and staff; trains site personnel; and supports regulatory or ethics committee submissions. Requires extensive monitoring experience, ideally in complex oncology or rare disease trials, fluency in English and French, strong organizational and communication skills, and national travel availability.

Performs and supports pharmacovigilance activities, including signal detection setup, line-listing review, complex signal detection reporting, quality control, signal evaluation, action recommendations, regulatory communications, tracking, and cross-functional compliance with procedures and regulations.

Leads the ICSR Management Unit, overseeing pharmacovigilance case-processing teams, resource allocation, productivity, budgets, quality activities, CAPAs, procedures, and business development. Manages Associate Directors and senior staff, supports recruitment and performance activities, analyzes workloads, coordinates cross-functional operations, and ensures high-quality delivery across post-marketing and clinical safety projects. Provides leadership, mentoring, process improvement, and client or commercial support.

Leads the ICSR Management Unit, overseeing pharmacovigilance case-processing teams, resource allocation, productivity targets, budgets, quality activities, CAPAs, procedures, and cross-functional coordination. Manages Associate Directors and senior staff, supports recruitment and performance activities, mentors managers, prepares operational analyses, contributes to proposals and business development, and ensures high-quality post-marketing and clinical safety operations.

Leads the ICSR Management Unit, overseeing staffing, productivity, resource allocation, budgets, quality activities, CAPAs, processes, and operational performance. Manages Associate Directors and senior staff, mentors line managers, supports recruitment and performance activities, contributes to proposals and business development, and coordinates with Quality, Operations, Analytics, HR, and other departments. Requires extensive pharmacovigilance case-processing experience across post-marketing and clinical settings, plus senior leadership experience.

Leads the ICSR Management Unit, overseeing staffing, productivity, resource allocation, budgets, quality activities, CAPAs, procedures, and operational performance. Manages Associate Directors and senior staff, mentors managers, supports recruitment and performance processes, coordinates across departments, contributes to proposals and business development, and ensures high-quality post-marketing and clinical case processing. Requires extensive pharmacovigilance experience and senior leadership capability.

Leads the ICSR Management Unit, overseeing pharmacovigilance case-processing teams, staffing, productivity, resource allocation, budgets, quality activities, CAPAs, procedures, and business development support. Manages Associate Directors and senior staff, establishes productivity targets, reallocates resources, mentors managers, supports recruitment and performance activities, and coordinates with operations, quality, analytics, HR, and commercial teams. Requires extensive post-marketing and clinical case-processing experience and senior leadership expertise.

Leads the ICSR Management Unit, overseeing staffing, productivity, resource allocation, budgets, quality, CAPAs, procedures, and project support. Manages Associate Directors and senior staff, mentors line managers, coordinates cross-functional activities, supports recruitment and performance processes, and contributes to business development. Requires extensive pharmacovigilance case-processing experience across post-marketing and clinical environments, with senior leadership experience.

Leads the ICSR Management Unit, overseeing staffing, productivity, resource allocation, budgets, quality activities, CAPAs, processes, and operational performance. Manages Associate Directors and senior staff, mentors line managers, supports recruitment and performance activities, prepares analyses, contributes to proposals and business development, and coordinates with operations, resourcing, quality, HR, and commercial teams. Requires extensive pharmacovigilance case-processing experience across post-marketing and clinical programs, with senior leadership experience.

Leads the ICSR Management Unit, overseeing resources, productivity, budgets, staff utilization, quality activities, CAPAs, procedures, recruitment, and business development. Manages Associate Directors and senior staff, reallocates resources, establishes productivity targets, supports proposals and contracts, coordinates with Quality and Operations, and drives process improvements. Requires extensive pharmacovigilance case-processing experience across post-marketing and clinical settings, plus senior leadership experience.

Manages an ICSR Management Unit, overseeing staffing, productivity, resource allocation, budgets, quality activities, CAPAs, procedures, and operational performance. Leads Associate Directors and senior staff, supports recruitment and performance management, prepares analyses, contributes to proposals and business development, and coordinates with quality, resourcing, operations, and project analytics teams. Requires extensive pharmacovigilance case-processing experience across post-marketing and clinical settings, plus senior leadership experience.

Leads the ICSR Management Unit, overseeing pharmacovigilance case-processing teams, staffing, productivity, resource allocation, budgets, quality activities, CAPAs, procedures, reporting, and business development. Manages Associate Directors and senior staff, mentors line managers, supports recruitment and performance management, coordinates with operations and quality teams, and ensures high-quality post-marketing and clinical case processing.

Oversee quality management, compliance, training, audits, regulatory intelligence, and CAPA activities for assigned pharmacovigilance client projects. Maintain project quality and training plans, ensure inspection readiness, review procedures and system access, monitor metrics and case quality, coordinate audits, manage deviations, and support risk assessments and corrective actions in accordance with global pharmacovigilance regulations and GxP requirements.

Supports project finance activities, including profitability monitoring, revenue and cash tracking, forecasting, budget and proposal preparation, payment schedules, backlog reconciliation, and audit support. Works with Project Managers to track project performance against budgets, identify margin risks and scope changes, and communicate financial observations. The role develops foundational expertise in project economics, financial modeling, and process improvement within a pharmaceutical and pharmacovigilance environment.

Manages clinical trial data activities from study start-up through database lock, including EDC and SAS edit-check validation, database testing, user account administration, query management, lab reference range tracking, medical coding, safety and vendor data reconciliation, reporting, documentation, and close-out support.

Builds and optimizes scalable data integration pipelines and infrastructure for enterprise analytics and business intelligence. Transforms, cleanses, and automates data preparation; monitors performance; troubleshoots bottlenecks; and implements data quality and governance standards. Collaborates with data scientists, analysts, IT teams, and business stakeholders to support AI, machine learning, and BI initiatives while maintaining data security, integrity, and regulatory compliance.

Performs and supports pharmacovigilance activities, including signal detection setup, line-listing review, complex signal detection reporting, quality control, signal evaluation, action recommendations, regulatory communications, tracking, and cross-functional compliance with procedures and requirements.

Leads study start-up and regulatory activities to achieve site initiation readiness across assigned countries and projects. Oversees regulatory submissions, essential documents, translations, site agreements, compliance reviews, trackers, and inspection readiness. Provides regulatory strategy, country intelligence, client guidance, risk escalation, and subject matter expertise while coordinating internal teams, sponsors, sites, and authorities. Also supports budgets, business development, SOPs, audits, and mentoring of junior staff.

Supports pharmacovigilance project activities, including Individual Case Safety Report processing, follow-up, SAE/SUSAR management, clinical and partner reconciliation, medical coding, quality complaint handling, reporting, workflow management, and regulatory PV support. May act as a local pharmacovigilance contact or responsible person for local screening.