Drug Safety Associate II
South San Francisco, CA | Contract
Bayside Solutions is seeking a Drug Safety Associate II to be part of our client’ s team in South San Francisco. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to save patients’ lives.
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.
Drug Safety Associate II
- 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:
- Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with Pharmacovigilance (PV) related standards, regulations and Standard Operating Procedures (SOPs) (~65% and as per business needs)
- The main responsibility is to perform data entry of adverse event case data through the receipt of local AE reports received from healthcare professionals or consumers. Assists in the timely completion of such AEs to submit to Roche global via the ARIS suite
- Performs the review of ancillary documentation accompanying Individual Case Safety Reports (ICSRs) for incorporation into the Global Safety Database
- Maintains and updates documents and trackers related to safety reporting as required
- Acts as single point of contact with key stakeholders for Safety related activities (~5%)
- Provides support to projects as assigned by and under the direction of the US Drug Safety Case Manager and/or other Safety personnel (~30%)
- Provides support during audits and inspections
Summary of Qualifications:
- College degree (Preferred)
- Computer proficiency (Required)
- Medical terminology experience (Preferred)
- Able to travel as per business needs
- Works effectively, independently and collaboratively
- Strong organizational skills, detail oriented and adapts in a fast paced, changing environment
- Demonstrates ownership, initiative and accountability
- Excellent communication skills, both written and verbal
- Ability to prioritize tasks in a timely manner
- Ability to interact effectively in a multi-functional, multidisciplinary team setting