Jobs at Ergomed

Conduct and lead pharmacovigilance audits across Europe, including planning, execution, reporting, follow-up, and CAPA development. Apply GVP and global regulatory expertise while delivering quality assurance projects for pharmaceutical and biotechnology clients. The role is freelance, available full-time or at least 0.6 FTE, supports remote audits, and requires up to 40% travel.

Acts as Australia’s local contact for pharmacovigilance and regulatory affairs, serving as the primary liaison with marketing authorization holders and regulatory authorities. Responsibilities include ADR and ICSR reporting, literature and regulatory intelligence screening, risk minimization oversight, local PV system support, regulatory submissions, product information review, quality tasks, documentation, audits, and inspections. Requires life sciences or equivalent qualifications, at least three years of relevant experience, knowledge of ICH GVP, and Microsoft Office proficiency.

Acts as Australia’s local contact for pharmacovigilance and regulatory affairs, serving as the primary liaison with marketing authorization holders and regulatory authorities. Responsibilities include adverse event and ICSR reporting, literature and regulatory intelligence screening, risk minimization oversight, local PV system support, regulatory submissions, product information review, quality tasks, documentation, audits, and inspections. Requires life sciences knowledge, at least three years of pharmacovigilance experience, and familiarity with ICH GVP and local requirements.

Provides administrative and operational support for pharmacovigilance technology consulting, system implementation, and managed services projects. Responsibilities include project setup, contract and documentation support, client onboarding and offboarding, renewal tracking, timesheet and resource utilization monitoring, project reporting, scheduling, and governance compliance. Coordinates with Project Managers, Operations, Finance, Human Resources, Delivery, and clients across multiple concurrent projects.

Manage clusters of related pharmacovigilance projects, overseeing scope, schedules, costs, risks, dependencies, quality activities, reporting, client relations, and escalations. Support program strategy, governance, process development, training, recruiting, sales proposals, demos, and practice development. Lead teams, allocate resources, analyze finances, manage stakeholders, and ensure timely, high-quality delivery.

Manage international oncology and rare disease clinical trials in a CRO environment, ensuring delivery on time, within budget, scope, and quality standards. Coordinate project teams, plans, meetings, training, SOPs, sponsors, senior management, scientific experts, and external service providers. Support regulatory alignment, study execution and closure, and bid defense activities.

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

Leads operational project management for complex clinical trials, identifying and mitigating risks, coordinating escalation, ensuring clinical team training, developing and revising study documents, and implementing corrective and preventive actions. The role requires extensive clinical research leadership across multiple studies and regions, experience with Phase 2/3 trials—ideally oncology or rare disease—and the ability to manage multiple projects in a fast-paced CRO environment.

Leads study start-up and regulatory activities to achieve site initiation readiness across assigned countries and projects. Coordinates regulatory submissions, essential documents, translations, site agreements, amendments, and compliance reviews. Develops regulatory strategies and study start-up plans, provides subject matter expertise, manages milestones, identifies risks, and liaises with internal teams, clients, sites, and external stakeholders while ensuring adherence to ICH-GCP and country-specific requirements.

Leads study start-up and regulatory activities to achieve site initiation readiness across assigned countries or projects. Coordinates regulatory submissions, essential documents, translations, site agreements, amendments, and compliance reviews under ICH-GCP and local requirements. Develops regulatory strategies and start-up plans, provides subject matter expertise, manages milestones, identifies risks, and advises internal teams, clients, and external stakeholders.

Leads study start-up and regulatory activities to achieve site initiation readiness. Manages submissions, essential documents, translations, site agreements, regulatory strategy, and country-specific compliance across Europe and/or the Americas. Coordinates internal teams, clients, and external stakeholders; provides regulatory expertise, identifies risks, and supports corrective actions while meeting timelines and quality standards.

Leads study start-up and regulatory activities to achieve site initiation readiness across assigned countries or projects. Coordinates regulatory milestones, submissions, essential documents, translations, site agreements, and compliance reviews under ICH-GCP and local regulations. Develops regulatory strategies and start-up plans, provides subject matter expertise, identifies project risks, and collaborates with clients, internal teams, sites, and external stakeholders to ensure timely, high-quality delivery.

Leads study start-up and regulatory activities to achieve site initiation readiness across assigned countries or projects. Responsibilities include managing regulatory milestones, preparing and reviewing submissions and essential documents, negotiating clinical site agreements, coordinating translations, ensuring ICH-GCP and country-specific compliance, developing regulatory strategies and start-up plans, and identifying project risks. The role serves as a subject matter expert and liaison among internal teams, clients, sites, and external stakeholders.

Leads study start-up and regulatory activities to achieve site initiation readiness across assigned countries or projects. Coordinates regulatory milestones, prepares and reviews submissions and essential documents, manages translations and clinical site agreements, ensures ICH-GCP and country-specific compliance, develops regulatory strategies and start-up plans, provides subject matter expertise, and identifies risks affecting timelines, quality, or deliverables.

Leads study start-up and regulatory activities to achieve site initiation readiness across assigned countries or projects. Responsibilities include managing regulatory milestones, preparing and reviewing submissions and essential documents, negotiating site agreements, coordinating translations, developing regulatory strategies and start-up plans, ensuring ICH-GCP and country-specific compliance, and identifying project risks. The role serves as a subject matter expert and liaison among internal teams, clients, sites, and external stakeholders.

Leads and coordinates clinical study start-up and regulatory activities to achieve site initiation readiness. Responsibilities include managing regulatory milestones, preparing and reviewing submissions and essential documents, negotiating site agreements, coordinating translations, ensuring ICH-GCP and country-specific compliance, developing regulatory strategies and start-up plans, and identifying project risks. The role provides regulatory expertise and collaborates with internal teams, clients, sites, and external stakeholders across multiple countries.

Leads study start-up and regulatory activities to achieve clinical site initiation readiness. Coordinates regulatory submissions, essential documents, translations, site agreements, and country-specific compliance across assigned countries or projects. Provides regulatory strategy and study start-up planning, reviews technical and legal documentation, manages milestones, identifies project risks, and supports corrective actions while serving as a liaison among clients, internal teams, and external stakeholders.

Leads study start-up and regulatory activities to achieve site initiation readiness across assigned countries or projects. Coordinates submissions, essential documents, translations, site agreements, regulatory strategy, and compliance reviews. Provides subject matter expertise, manages milestones, identifies risks, supports corrective actions, and liaises with clients, internal teams, sites, and external stakeholders while ensuring adherence to ICH-GCP and country-specific requirements.

Leads regulatory and pharmacovigilance deliverables for complex projects, serving as the local pharmacovigilance contact. Responsibilities include regulatory strategy, project coordination, risk management, vendor and budget oversight, invoice review, training compliance, audit support, regulatory intelligence, KPI reporting, proposal support, and mentoring junior staff.

Develop regulatory and pharmacovigilance strategies, coordinate complex project deliverables, and serve as the designated country’s Local Contact Person for Pharmacovigilance. Manage LCP records, training compliance, budgets, invoices, KPIs, vendors, regulatory intelligence, audits, and inspections. Provide client support, risk mitigation, coaching, proposal input, and contributions to SOPs and company initiatives while ensuring compliance with applicable regulations.