Pharmacovigilance Scientist Job at R&D Partners, Cambridge, MA

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  • R&D Partners
  • Cambridge, MA

Job Description

Job Description

R&D Partners is seeking to hire a Pharmacovigilance Scientist in Cambridge, MA.

Your main responsibilities as a Pharmacovigilance Scientist :

  • Works closely with the safety physician to analyze potential safety issues, including signal detection, signal evaluation and signal management
  • Contribute to signaling and data mining activities utilizing internal and external sources of data
  • Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests
  • Assist in the evaluation of potential safety issues and quality risk assessment reports utilizing all processes and templates
  • Together with safety physician manages leads the authoring for aggregate safety reports (e.g. PSUR, DSUR, Line listings) in close collaboration with the cross functional lead and operational functions
  • Supports all SRMT preparation and documentation with guidance from mentor and safety physician
  • Working with affiliate management and regulatory to develop and edit SMPs/ESRPs and independently bringing issues related to SMPs and ESRPs for discussion with impacted parties
  • Contribute to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes, and meeting documents; ensuring completion of action items; and participating in the discussion of patient safety issues

What we are looking for in a Pharmacovigilance Scientist :

  • Degree in a medical or healthcare related discipline (MSN RN, PharmD, Physician Assistant, MD) is required
  • A minimum of three to five years in the pharmaceutical industry with experience in drug safety/pharmacovigilance
  • ARGUS and Empirica PSUR, DSUR for Aggerate reporting
  • Must have clinical background
  • Authoring experience
  • Very analytic

Why Choose R&D Partners ?

As an employee, you have access to a comprehensive benefits package including:

  • Medical insurance PPO, HMO & HSA
  • Dental & Vision insurance
  • 401k plan
  • Employee Assistance Program
  • Long-term disability
  • Weekly payroll
  • Expense reimbursement
  • Online timecard approval

Salary:

  • $74.98 to $81.50 (Dependent on Experience)

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.

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