Drug Safety Associate I
350 DNA Way, SSF35 South San Francisco, CA 94080 | Contract
Bayside Solutions is seeking a Drug Safety Associate I 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 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:
- Establishing work priorities and direction independently with minimal input from Manager.
- Collecting, documenting, and processing adverse event (AE) reports from clinical trials and post-marketing sources in accordance with company Standard Operating Procedures (SOPs) and work practices to ensure and maintain regulatory compliance.
- This includes detailed review of source documentation, assessing cases for reportability, accurate data entry, and quality check.
- Preparing clinical narrative summaries independently for AE reports from clinical studies and spontaneous post-marketing reports and formulates follow-up information requests.
- Performing active follow-up via telephone contact with consumers and health care professionals.
- Coding all AEs in MedDRA independently.
- Ensuring timely reporting of SAEs/AEs to Regulatory Authorities, and cross-reporting to pharmaceutical partner(s).
- Participating in the preparation of aggregate safety reports, such as biannual safety reports to Ethics Committees and annual reports to regulatory authorities.
- Conducting periodic reconciliation of SAEs between drug safety and clinical trial databases for ongoing clinical studies with little or no supervision.
- Representing the DSRM department on project teams.
- Completing individual projects in support of DSRM department initiatives.
- Working with Clinical Research Department and Contract Research Organizations, sometimes in a lead capacity, regarding information exchange and safety exchange agreements.
Summary of Qualifications:
- Health care professional degree (PharmD, RN, MD) with at least 2 years drug safety experience AND additional clinical or pharmaceutical experience.
- Strong verbal and written communication skills demonstrated by the ability to interpret and communicate medical information and write summary reports, if needed.
- Strong interpersonal skills especially for proactive drug safety representation on clinical/project team and investigator meetings, and communications with contract research organizations (CROs) involved in safety reporting.
- Candidate must have the ability to organize workflow activities, able to multi-task, be performance-driven, and possess good decision-making skills.
- Computer literacy including working knowledge of computer applications such as word processing, spreadsheets and electronic mail is required; experience with data entry into drug safety databases strongly desired; ARISg experience a plus.
- Knowledge of domestic and international drug safety regulations, industry practices and standards as well as clinical knowledge in appropriate therapeutic area is preferred.