Drug Safety Scientist
This is an exciting opportunity for an experienced Safety Scientist to join a Gene therapy company. Orchard Therapeutics has a vision to be the leader in gene therapy and rare diseases. This role offers a fantastic opportunity for an experienced safety scientist to progress their skills, knowledge and career in this fast-growing therapeutic field.
The Safety Scientist is responsible for carrying out pharmacovigilance activities on a group of products. This may include single safety case review, aggregate reporting, signal detection and evaluation, safety activities associated with new drug applications/regulatory filings, benefit risk assessment, review and input in clinical study reports, protocols, IB, DSURs and PBRERs, labelling matters, interactions with the sites, and managing vendors. This is a hands-on role where often the team is working to very tight timelines.
Prior knowledge and experience of:
- Safety case processing, coding, assessing seriousness, expectedness and causality and conducting aggregate case analysis
- Conducting the analysis of similar events for FDA reporting purposes
- Interaction with Health Authorities and Data Safety Monitoring Boards
- Experience of dealing with safety and clinical vendors
- Identification of potential clinical safety issues and proposing risk prevention and/or mitigation measures and conducting or assisting in safety reviews
- Assistance in preparation and maintenance of Risk Management plans, periodic safety reports (PBRER / PSUR, DSUR and other Annual Safety Reports)
- Assisting or conducting signal detection and evaluation according to SOPs and guidelines
- Reviewing /developing safety parts of protocols, study reports, Investigators Brochure and other PV documents
- Assisting/contributing to regulatory agency submissions (IND applications, NDAs, MAA’s, Variations, Renewals) by reviewing safety data and assisting in preparing relevant sections of the filing documents and submission packages
- Assisting in the review and development of trial related documents such as protocols, IB, informed consent forms, study reports and outputs, clinical overviews and narratives.
- Contributing to the development of SOP, guidance and Pv templates and check-lists
Education & skills
- BSc; MSc; PhD; PharmD or equivalent qualification in Biosciences
- Prior experience in drug safety is required including the knowledge of safety reviews, signal detection and periodic reports, labelling and risk management of compounds in development and products on the market
- Good knowledge of US and EU pharmacovigilance regulatory requirements
- Excellent written and verbal communication skills and ability to present and critically discuss safety data
- Team player with ability to function in a small team with tight timelines
- A can-do attitude and a self starter
- Attention to detail
All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.