Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Due to continued growth, CRG is now looking to appoint an Medical Director/Senior Medical Director of Medical Monitoring, PVG, to join our team of Medical Monitor team in Asia Pacific. This role will be home based in Australia.
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The Medical Director/Senior Medical Director will be responsible for providing medical monitoring service for global clinical studies and safety evaluation under global medical monitor team within the PPD Pharmacovigilance department.
A day in the Life:
Provide study, project and program-specific medical monitoring and review services, including but not restricted to:
Leading of all medical aspects of contracted tasks. Supervising of safety variables.
Discussing with clients, investigators and healthcare professionals of medical issues in the pre and post approval services by using accurate medical judgment, interpretation and decision.
Provide medical consultation to team members and answer study related medical questions. Communicate clearly with associates and clients, maintaining and open line of communication to ensure all procedures are followed appropriately.
Analysis and assessment of safety data to identify and run emerging safety signals.
Medical review of individual case safety reports, serious adverse event reports and clinical outcome reports.
Assist in Business Development activities.
Present PPD standard medical safety processes to clients at business development meetings and connect with various medical communities to explore and expand PPD business.
Participate in training of project teams.
Provide therapeutic and protocol training as needed.
Write, review and approve reports, regulatory submissions and protocols, ensuring that the medical content is accurate and complete.
Keys to Success:
Education and professional experiences
- MD degree and strong medical knowledge, validated clinical experience handling patients in hospital settings
- At least 10 years of experience as a medical monitor within pharmaceutical industry including pharmaceutical companies or CRO
- Experiences of leading medical monitoring services across APAC in global studies
- The experience of safety physician is a plus
- Receiving medical education in Australia
- Profound experiences in medical monitoring of vaccine and infectious disease studies
- Experiences of oncology studies as a medical monitor
- Experiences of early phase studies as a medical monitor
- Experiences of working with sites in Australia as a medical monitor
- Experiences of large scale studies which enrolls thousands of patients within a short period of time as a medical monitor
- Willing to work flexibly and handle urgent issue during off hours, weekends and bank holidays
- Is proficient in spoken and written English
- Solid understanding of regulatory guidelines for adverse event reporting
- Strong communication & presentation skills and is a strong standout colleague
Physical Requirements / Work Environment:
PPD values the health and wellbeing of our employees. We support and encourage individuals to build a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Able to work in non-traditional work environments.
- Able to use and learn standard office equipment and technology with proficiency.
- Able to perform optimally under pressure while prioritizing and balancing multiple projects or activities.
- This role requires independent travel up to 35%, inclusive of traveling in automobiles, airplanes, and trains.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.