Brisbane, CA | Contract
Bayside Solutions is seeking a Pharmacovigilance Specialist to be part of our Client’ s team in Marin County. This is an opportunity to work with a local Biopharmaceutical company focusing on the developing and commercializing novel therapies for rare diseases.
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. Their company has been recognized as one of the fastest drug developers in the industry and has also been recognized among the Top 10 World’ s Most Innovative Company’ s in 2015 & 2016.Their organization is fueled by their employee’ s passion and dedication to change the course of disease.
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.
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- 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:
- Performs triage for all incoming cases (including the following clinical assessments: seriousness, listedness/labeledness, and causality)
- Determine follow up requirements and perform follow up for all case types
- Performs review and assessment of the validity of literature abstracts and articles
- Performs accurate data entry and narrative creation for all individual case safety reports
- Participates as the PV representative in Project Team Meetings for assigned projects (including protocol and ICF review, development of SRPs, Safety Reporting presentations at Investigator Meeting and reconciliation activities)
- Develop and maintain product and disease state knowledge for all Company products
- Ensure departmental workflow processes and timelines are followed
- Assure and maintain compliance with regulatory and local/global timelines
- Health care professional degree required (RN, BSN, PA, NP, PharmD or MD)
- Minimum of 3-5 years Pharmacovigilance experience.
- Previous experience with safety database application(s)
- Thorough knowledge of medical terminology essential.
- Strong knowledge of MedDRA
- Knowledge of Pharmacovigilance and processes, knowledge of appropriate regulations and related timelines
- Skill requirements: ability to work in a team environment, strong organization skills, detail oriented, meet tight deadlines, strong communication skills both verbal and written, demonstrate computer proficiency, demonstrated initiative and accountability.
- Strong knowledge of internal medicine, epidemiology, physiology and pharmacology