Global Senior Safety Scientist
MSI Pharma is currently working with a Small Global Pharmaceutical company to help them hire a Freelance Senior Safety Scientist to join their team in Basel.
Main Focus:

· Manage case processing for clinical trials and electronic reporting to EMA;
· Ensures oversight of our PV vendor
· Manages interactions with internal departments as well as vendors, commercial partners and CROs
· Coordinates and contributes to Development Safety Update Reports (DSURs) and writes Safety Management Plans
· Ensures Signal detection activities for products in development are completed as a member of the Safety Assessment Committee;
· Ensures the appropriate filing of clinical safety documents in the eTMF
· Perform QC for SAEs and reports SUSARs to EMA using the Eudravigilance system
· Ensure reconciliation of safety data between the Clinical and Safety databases in collaboration with our license partners when applicable
· Supports for quality assurance activities (writing quality documents, template documents and CAPAs

Experience & Qualifications:
· Bioscience graduate (BSc, PharmD)
· Fluent in written and spoken English
· Awareness of pre- and post-marketing PV legislation
· 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

Key words:
Pharmacovigilance, Permanent, Safety Data, PV, Drug Safety, Global Safety, Risk Management,