Expiry Date: 31-05-2023
Category R & D
Job Type: Full Time
San Francisco County
My team and I have a brand-new opportunity that we are excited to bring to your attention, which is yet to be openly advertised anywhere else! A small but very profitable and financially stable R&D biopharmaceutical company working on an expanding line of first-in-class therapeutics is looking for a new Global Safety Lead to start of as a Senior Director and serve as the safety expert accountable for the global safety strategy and profile for both investigational and marketed products throughout their lifecycle.
The company applies its pioneering expertise to advance innovative treatments for patients with unmet needs. The team is very inclusive on all levels, comprised of passionate and committed professionals striving to support all new-comers who share the same goals as they do - helping those who need it the most.
To help you find out if this is the right career move for you, here are some of the Key Duties:
- As a Global Drug Safety Lead, you will be presented with the opportunity to manage all pre and post marketing safety surveillance activities in compliance with ICH, FDA, EMA guidelines and regulations related to GVP.
- You will also provide medical review of individual case safety reports and all safety analyses to ensure accurate coding (MedDRA and WHODrug), seriousness, expectedness and company causality assessment, appropriate medical interpretation, consistency in case assessment and accurate reporting to Health Authorities, Ethics Committees, and partners
- Direct the creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labelling.
- MD degree or equivalent (e.g., DO or MB) and board certification required, knowledge in either oncology or fibrosis is a plus
- 3-5 years of biopharma industry experience is required, with a focus on patient safety or prior pharmacovigilance experience preferred
- Good knowledge of pharmacovigilance regulations
- Proven evidence of effective delivery of high-quality safety documents
- Technical expertise in patient safety gained from experience in a PV or a clinical background, including understanding of adverse events, adverse drug reactions, reporting systems, pharmacologic principles behind these adverse events, and measures to ensure patient safety
The role comes with a substantial package with a strong base salary, an exceptional bonus, and a significant stock plan. You can also work fully remote, anywhere in the US.
If you are interested in applying for this role, my team and I would be happy to present you with more information and guide you through the process!
To apply for this role, please contact me, Matt Greig on +1-908-332-9157 or send a full CV to my colleague Christian at Christian@AdvTalent.com and we will reply by return. Our team will support you throughout the interview and on-boarding experience.
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