Safety Scientist III
350 DNA way South San Francisco, CA 94080
Bayside Solutions is seeking a Safety Scientist III to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Safety Scientist III
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Develop timely and scientifically sound clinical safety portions of a Product Development Plan (PDP), develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant strategic context (e.g., disease under study, safety profile of competitors, mechanism of action)
- Contribute to development the product safety strategy and provide drug safety input into the Clinical Development strategy aligned with the safety strategy and risk management plans (e.g., Integrated Safety Management Plan (ISMP), RMP)
- Review of clinical protocols, study reports, Investigator' s Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication
- Contribute to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with a safety science physician.
- Accountable for signal detection, evaluation and decision-making across the lifecycle of the product.
- Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable
- Prepare and present (or support presentation) of important safety issues to the Drug Safety Committee (DSC), Development Review Committee (DRC) and other internal and external review and governance committees as needed.
- Author or contribute to scientific publications (abstracts, posters, papers) for scientific meetings/journals
Summary of Qualifications:
- Completed MD degree and postgraduate training with 4 or more years of academic experience. Specialty training and board certification or equivalent (current or past) required, or completed MD degree and postgraduate training with 2 or more years of clinical or academic experience and 2 or more years of drug safety, clinical development or medical affairs experience in the pharmaceutical or related industry
- Demonstrated team leadership in industry or academic setting
- Experience in the principles and techniques of data analysis, interpretation and clinical relevance
- Experience publishing in a refereed journal preferred
- Understanding of GxP and regulated processes and end-to-end clinical trial lifecycle
- Strong orientation towards cross-functional teamwork
- Effectively work with remote partners on a global team
- Excellent written and verbal English communication skills