Pharmacovigilance Associate Scientist II
- Provide medical oversight for Novotech sponsored clinical trials.
- Prepare Medical Monitoring Plans and review client protocols.
- Mentor and manage a small team of medical monitors.
The Senior Medical Services Manager will be responsible for performing higher complexity medical monitoring tasks, including those as a global/program medical monitor. The Senior Medical Services Manager may also mentor/line manage a small number of assigned medical monitors. The activities will include coordination and delivery of training, participation in the development and revision of medical monitoring SOPs, contribution to improving the performance of the medical monitoring team and close liaison with Business Development in medical guidance on protocol and project requirements.
Only candidates with unrestricted working rights in Australia can be considered for this role.
Responsibilities include:
- Provide medical oversight for Novotech sponsored clinical trials, acting as medical representative to the Novotech project team.
- Prepare a Medical Monitoring Plan for each study according to project scope.
- Provide medical review and commentary on client protocol and/or Investigator Brochure.
- Attend Investigator Meeting; prepare and present safety or medical aspects if required.
- Provide medical review and input to Clinical Monitoring Plan and Safety Management Plan as required.
- Provide medical review, comment and assessment of causality for Serious Adverse Events (SAEs) occurring in Novotech sponsored clinical trials.
Experience and Qualifications:
- Must be qualified as a medical Doctor with experience in clinical practice.
- Experience in drug development in the pharmaceutical and/or CRO industry.
- Knowledge of drug safety reporting requirements and practice.
Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
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