Safety Scientist III
350 DNA Way South San Francisco, CA 94080
Bayside Solutions is seeking 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:
- Carry out pharmacovigilance and risk management activities for specific product or products:
- Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues
- Support the preparation and maintenance of Risk Management plans
- Prepare and review periodic safety reports (PBRER / PSUR, DSUR, EU renewal and other Annual Safety Reports) in accordance with regulatory requirements and standard operating procedures
- Support the preparation and maintenance of safety sections of the Company Core Data Sheet
- Lead/support PDS post-marketing safety study activities
- Coordinate safety activities between PDS and internal and external partners
- Carry out signal detection activities and evaluation:
- Conduct/support signal detection and evaluation according to SOPs and guidelines
- Carry out medical review of individual case safety reports (ICSRs), if assigned for the product according to SOPs and guidelines Prepare safety assessments, drug safety reports, as necessary, for potential signals or issues (product quality)
- Respond to safety requests for the assigned product from regulatory agencies or affiliates/ other internal functions
- Contribute drug safety input to activities to define and implement the Clinical Development strategy for a product or group of products:
- Provide safety content review of clinical protocols, study reports, Investigators
- Brochure and other related documents to ensure alignment with CDP
- Contribute to regulatory agency submissions (IND applications, NDAs, MAA’ s, Variations, Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages
- Participate in or provide input for Drug Safety
- Monitoring Boards or independent monitoring committee meetings, as applicable
- The Safety Scientist should develop a clear understanding of the safety issues and a thorough knowledge of the from the drug mode of action, to enable support the SSL
- The timely medically and scientifically sound development of the clinical safety portions of a product development plan (PDP) and develop an understanding of the safety profile of the assigned product Whenever assigned by the SSL,
- The Safety Scientist is responsible for the development and whenever appropriates the execution of RMP or REMS risk mitigation tactics
- Minimum: PhD, PharmD, Pharm, MS or equivalent qualification Strongly desired: MD, PhD or PharmD Preferred, Bioscience Degree
- Prior industry experience in drug safety, clinical development or medical affairs is desirable MD candidates - clinical practice experience (at least 3 years preferred, may include residency)
- Good knowledge of pharmacovigilance practices Good knowledge of US and EU pharmacovigilance regulatory requirements
- Excellent written and verbal communication skills and ability to present and critically discuss clinical data in both internal and external discussions
- Ability to evaluate, interpret and synthesize scientific data (analytical thinking)
- Team player with ability to function in a multi-disciplinary environment Self – motivated, able to prioritize and plan effectively