• Safety expert of the assigned product(s), establishing the strategy, direction, and priorities of pharmacovigilance activities. • Accountable for the overall safety profile and all product-related decisions and deliverables for assigned products. • Leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). • Product safety profile, benefit-risk evaluation, and risk communication • Clinical trial safety Brochure and Informed Consent Form • New drug applications and other regulatory filings • Risk management and minimization • Commercialization Process • Inspection Readiness • Partnerships and integration activities • Participate in safety agreement development and review process • Prepare safety information to support licensing partners, review safety documents prepared by licensing partners, and communicate with licensing partners on safety matters per the safety agreement

Role Description We're seeking a skilled and empathetic Medical Doctor to join our team as a founding physician for our new Australian clinic. The ideal candidate will be passionate about women's health, comfortable with virtual care delivery, and excited to help shape a brand new service from the ground up. In This Role, You'll Make an Impact By: - Conducting expert virtual consultations for menopause assessments. - Delivering comprehensive follow ups for menopause related concerns, ensuring continuity of care and patient satisfaction. - Crafting personalized treatment plans tailored to each patient's unique needs. - Prescribing and managing menopausal hormone therapy (MHT) and other treatments. - Empowering patients through education on lifestyle modifications and self care strategies. - Collaborating seamlessly with our dedicated physician team. - Enjoying the benefits of our state of the art intake process. Qualifications - Current registration as a medical practitioner with the Australian Health Practitioner Regulation Agency (AHPRA). - A valid Medicare provider number (or eligibility to obtain one). - Current professional indemnity insurance valid in Australia (e.g. Avant, MDA National, or MIGA). - Proficiency in virtual care delivery and telehealth platforms. - Excellent communication skills and a patient centered approach. - Familiarity with EMR systems, or willingness to learn. - Ability to work independently and as part of a collaborative team. Requirements - Fellowship of the Royal Australian College of General Practitioners (FRACGP), or equivalent specialist qualification. - Interest, specialized training, or certification in menopause management. - At least 1 to 2 years of experience in women's health, general practice, or a related field. - Experience with menopausal hormone therapy (MHT) is an asset. - Interest in contributing to clinic growth and service expansion as we establish our presence in Australia. Benefits - The opportunity to help launch and shape a new clinic as we enter the Australian market. - Specialize in an important and often underserved area of women's health. - Flexible work arrangements that fit your lifestyle. - Collaborative team environment with supportive physician leadership. - Chance to shape the future of virtual menopause care in Australia. Compensation - Contract position (minimum of 10 hours per week). - Part time or full time. - Flexible hours based on candidate availability. - Compensated on a per assessment basis, depending on complexity of patient.

• Serve as the CLIA Laboratory Director for Spear Bio’s high-complexity clinical laboratory. • Provide overall clinical, scientific, and regulatory oversight of CLIA-certified laboratory operations. • Ensure compliance with all applicable regulatory and accreditation requirements, including CLIA, CAP, and NY State CLEP, as applicable. • Oversee quality management program to ensure accurate, reliable, and timely laboratory testing. • Review and approve laboratory policies, procedures, test validations, and quality documentation. • Monitor laboratory performance and implement continuous quality improvement initiatives. • Provide clinical consultation to physicians and other healthcare providers regarding laboratory testing and test results. • Support laboratory readiness for regulatory inspections and accreditation surveys. • Foster a culture of quality, compliance, and scientific excellence.

Role Description PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being. Home-Based in Brazil Responsibilities: - Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questions - Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions - Monitors trial participant safety - Participates in trial participant recruitment boost and retention activities - Presents on medical matters at kick-off and investigator meetings - Trains trial team in the therapeutic area and medical aspects of the protocol - Develops and reviews trial-specific documents within the scope of medical monitoring - Manages ongoing trial risks related to medical monitoring - Performs ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trial - Reviews protocol deviations - Reviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues - Reviews IND/SUSAR Safety Reports, updates/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request) - Participates in management of trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) as described in the corresponding trial-specific charter(s) - Supports Pharmacovigilance, Medical Data Review and Data Management with reconciliation of safety and operational clinical trial databases - Reviews clinical study reports (CSRs), including safety narratives and tables, figures, and listings (TFLs) - Provides medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverable - Prepares for and participates in trial audits, follows up on audit findings - Participates in feasibility assessment of potential and ongoing trials in the country/region - Participates in bid defense meetings and other interactions with clients - Acts as a medical expert and provides therapeutic expertise to other PSI departments Qualifications - Medical Doctor degree required - Experience as a practicing Gastroenterologist (minimum of 10 years) - Clinical Research experience preferred - Full working proficiency in English and Portuguese - Proficiency with MS Office applications - Communication, presentation and analytical skills - Problem-solving, team and detail-oriented Additional Information As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.