Global Senior Safety Scientist
MSI Pharma is currently working with Growing Biotech to help them hire a permanent Senior Safety Scientist to join their team in Basel. The team is currently small, so the new hire will have the chance to get involved with a wide range of safety activities with the end goal being a successful regulatory submission.
Main Focus:
To support the department head with scientific analyses, data reviews, signal management and risk assessment activities, evaluation of product quality issues and emerging safety issues, including contribution to safety documents
- Ensure high quality, accurate scientific contributions to the safety evaluation of products both during development and after marketing authorisation approval
- Contribute to the preparation and review of pharmacovigilance documentation for internal and external use
- Ensure the timely provision of all safety deliverables to enable progress with clinical trials (interventional and non-interventional), including facilitating the activities of Data Safety Monitoring Committees
- Overall contribution to Global Patient Safety vision and compliance
Experience & Qualifications:
- Bioscience graduate (BSc, PharmD)
- Fluent in written and spoken English
- Awareness of pre- and post-marketing PV legislation
- Proven scientific analytical skills
- Previous experience of pharmacovigilance, either in industry or in a health authority
- Knowledge of product development processes and experience of cross-functional team work
- Sound knowledge of pharmacovigilance legislation
- Prior experience with NDA/BLA or equivalent regulatory submissions, or experience working in a Regulatory Agency reviewing submission files
- Experience with Aggregate reports, and safety sections of regulatory documents
Key words:
Pharmacovigilance, Permanent, Safety Data, PV, Drug Safety, Global Safety, Risk Management,
