• Maintain responsibility for the execution and oversight of the region’s clinical operations functions • Drive regional adherence to our evolving clinical tenets • Own full P&L for region(s) • Manage fixed costs • Assist in improving upon the strategy and framework for aligning the clinical assessment • Drive accountability to clinical outcome measure completion • Ensure high-quality and ethical care • Oversee adherence and compliance with external regulations • Drive regional clinical and compliance improvement at the center level • Lead, develop, mentor and engage a team of center leads • Serve as the regional clinical subject matter expert • Foster a metrics driven culture

Title: Medical Safety Lead (client-dedicated), EMEA Location: Remote EMEA Full time The Medical Safety Lead is going to lead and perform the assessment of medical safety data for assigned products, develop and execute safety signaling and benefit-risk management strategies, closely collaborate with stakeholders internally (e.g. Regulatory Affairs, clinical development, medical affairs) and externally (e.g. Key Opinion Leaders or regulatory agencies) to align safety communications and to ensure the safe use of client`s products. A day in the Life: - Provide strategic medical safety leadership and practical contributions for assigned product(s) in a cross-functional setting - Perform safety signal management and benefit risk assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews as needed for assigned product(s) - Lead cross-functional teams to perform regular and/or ad-hoc review of existing and emerging aggregate safety data for assigned product(s) - Contribute to the development of the overall safety governance structure and activities - Provide safety strategies and deliver accurate, timely and high-quality safety contributions for the preparation of relevant sections of regulatory submission documents globally (e.g. ISS, SCS, narratives) for assigned product(s) - Prepare and/or review safety sections of clinical/regulatory documents (including study protocols, IBs, Clinical Study Reports, or ICFs) - Provide medical safety support for the preparation of responses to regulatory authority inquiries. Assure that safety information is timely, complete, and accurate - Lead the overall preparation of periodic safety reports (e.g. PSUR, DSUR); provide medical safety content and ensure consistency and quality of these documents - Oversee the medical assessment of individual case safety reports (ICSR) - Confirm criteria and content for expedited reporting and unbinding (e.g. SUSAR or urgent safety issues) - Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB) - Provide medical safety contributions at internal audits and regulatory inspections - Support the development of and updates to GPS Standard Operating Procedures (SOPs) and other controlled documents (e.g. work instructions, forms, templates) - Support adverse event reporting training and pharmacovigilance awareness activities cross functionally - Support the preparation of pharmacovigilance agreements with clinical development or commercial business partners - Participate in cross-functional teams and initiatives Keys to Success: - Strong scientific and analytic skills - Ability to complete multiple tasks concurrently and deliver results in a fast-paced environment - Strong ability to lead, motivate, influence, and collaborate with multidisciplinary teams - Excellent presentation skills with the ability to communicate complex issues clearly Education and Experience: MD required. History of an active medical license highly preferred. Candidates should have: - Clinical experience in having direct responsibility for diagnostic and treatment decisions (2+ years); - Direct experience in medical review and assessment of safety information/Pharmacovigilance (5+ years). Knowledge, Skills and Abilities: - Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents - Demonstrated ability to perform medical assessments of safety data from multiple sources - Experience with authoring complex documents and contributing to regulatory submissions - Knowledge of adverse event reporting systems - Experience in epidemiology, biostatistics, clinical development, or medical affairs is a plus

Title: Medical Director/Senior Medical Director Rheumatology (Client dedicated) Location: Buenos Aires Buenos Aires Argentina Full time Remote The Associate Medical Director provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports ( e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR). We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. What You'll Do: Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle. General Support: • Ensure tasks delegated to PV are properly executed. Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Follow client SOPs/directives and project-specific WPDs for assigned projects. Comply with CRG’s corporate policies and SOPs/WPDs. • Provide medical consultation to team members and answer all study-related medical questions. Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately. • Provide therapeutic training and protocol training on assigned studies, as requested. • Assist in writing (interpretation of safety and efficacy data) and/or reviewing CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc., to ensure that the medical content is accurate and complete. Clinical Trial Support: • Monitor all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies. • Discuss all medical concerns with principal investigators and clients (e.g., interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in interpretation and decision-making regarding clinical situations as they relate to the investigational study. • Provide medical review of adverse events of special interest, serious adverse events, and clinical outcomes events reported by study sites. • Perform data review as specified in the client contract and data validation manual, including review of coding listings and/or full safety data to assess potential safety concerns. Marketed Products Support: • Manage signal detection activities, scientifically review aggregate reports, contribute to label updates, and support dossier maintenance and risk management activities. • Medically review adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted. Education and Experience Requirements: • MD or equivalent required. Active medical licensure preferred. Candidates should have at least one of the following: • Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training (comparable to 2 years). • Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry. • Direct experience in safety/Pharmacovigilance (comparable to 2 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, Abilities: • Therapeutic expertise across one or more medical specialty or sub-specialties • Strong decision-making, problem solving, organizational skills and analytical skills • Excellent oral and written communication skills • Working knowledge of relevant safety databases (e.g. Medra) • Flexibility to travel domestically and internationally • Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information • Proficiency in basic computer applications • Fluent in spoken and written English • Excellent interpersonal, influencing and team building skills • Understanding guidelines (FDA, ICH, EMA and GCP) • Working knowledge of biostatistics, data management, and clinical operations procedures • Ability to act as a mentor/trainer to other staff within PV

Title: Medical Typist Location: Townsville Australia Salary Other$39.98-$44.46 p.h. Permanent Position type Part-time 64 hours per fortnight This role delivers exceptional person-centered customer service to patients, their families and the public. The role works collaboratively as a member of the administrative team and provides quality support to deliver a high standard of organisational and patient-focused outcomes. This role contributes to creating an exceptional place to work by consistently aligning workplace behaviours to organisational values. The ideal applicant will be someone who has proven ability and can demonstrate the following: - Demonstrated ability to effectively, efficiently and accurately transcribe clinical dictations from analogue and/or digital dictation systems. - Demonstrated knowledge of medical terminology, abbreviations and symbols or demonstration of transferrable experience which would support the ability to quickly adapt within a health environment. - Knowledge of, or the ability to acquire knowledge of, and experience in the use of Microsoft Office programs, including keyboard functionality, formatting and shortcuts. - Sound oral and written communication skills with advanced interpersonal skill demonstrating ability to effectively liaise and communicate with clients and staff of all levels with tact, diplomacy, confidentiality and discretion on a range of confidential and sensitive issues. - Proven ability to work effectively as an individual with limited supervision or collaboratively within a multidisciplinary team, establishing work priorities, meeting deadlines, co-ordinating tasks and workflow and adapting as required to meet the needs of a changing work environment. - Knowledge and understanding of the relevance and application of values-based workplace behaviours and attributes. - Demonstrated awareness of, and ability to actively and effectively participate in a working environment supporting contemporary human resource practices including workplace health and safety, employment equity and anti-discrimination, ethical behaviour and continuous improvement. About your new employer Supportive Workplace Culture and Regional Advantage A strong community-driven culture makes our organisation an attractive workplace, fostering collaboration, inclusion, and professional support. We balance metro-level healthcare opportunities with a regional feel, offering short commutes, access to rural and urban facilities, and a close-knit professional network. Work/Life Balance and Lifestyle Benefits Townsville HHS prioritises employee wellbeing, offering flexible work arrangements, stable job security, and a family-friendly environment. Staff benefit from regional opportunities while maintaining modern healthcare advantages. Role requirements - Whilst not mandatory previous experience working in a similar role would be highly desirable. - This is a VPD risk role. Hepatitis B, Measles, Mumps, Rubella, Varicella, Pertussis and Tuberculosis. Please refer to the Role Description for further details. Competitive salary and benefits: We offer attractive remuneration packages and generous leave entitlements. - Salary range: $39.98 - $44.46 p.h. (AO3) - 4 weeks annual leave (pro rata) with 17.5% loading - Locality allowance - 12.75% employer contribution to superannuation - Plus Salary Sacrificing options may be available