Safety Scientist I
301 DNA Way South San Francisco, CA 94080
Bayside Solutions is seeking Safety Scientist I 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 I
- 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:
The CSSD Safety Scientist is responsible for carrying out pharmacovigilance activities on a product or group of products.
- Carry out pharmacovigilance and risk management activities for specific product or products: 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.
- 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.
- Provide safety content review of clinical protocols, study reports; The CSSD Safety Scientist should develop a clear understanding of the safety issues and a thorough knowledge of them from the drug mode of action, to enable support the SSL.
- Bachelor' s degree in healthcare related field or equivalent experience.
- Prior work experience in pharma safety, pharmacovigilance or other related pharma development area is highly preferred for this current role.
- 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.
- Attention to detail Fluent in English (verbal and written)
- Good negotiating and influencing skills Good computing/IT skills