Pharmacovigilance Specialist II

  • location: Brisbane, CA
  • type: Contract
  • salary: $29.43 - $34.62 per hour
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job description

Pharmacovigilance Specialist II

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare genetic diseases, our partner strives to develop critical therapies for the small population - mostly children - that suffer from near unheard of conditions. If you're looking for an exciting opportunity to make a difference with an established company, this is the position for you!

 
location: Brisbane, California
job type: Contract
salary: $29.43 - 34.62 per hour
work hours: 9 to 5
education: Bachelors
 
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
 
qualifications:
  • 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
 
skills: Pharmacovigilance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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