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Principal Scientist, PVRM
Ref No.: 17-13992
Location: Marlborough, Massachusetts
Start Date / End Date: 11/13/2017 to 11/09/2018
Job Title: Principal Scientist, PVRM
Duration: 1 year(Temp-to-perm)
Location: Marlborough, MA

Job Description:
Signal Detection and Medical Surveillance Activities 40 % of Time
  • Independently evaluates data, identifies opportunities and risks, weighs alternatives and presents analyses to Medical Director for review.
  • Organize planned and ad hoc safety review activities - Obtain data for signal assessment (e.g., Oracle AERS, FDA AERS data, literature search); generate/request listings, identify cases, prepare initial assessment for review and finalization by Medical Director, follow-up on meeting outcome (as needed), ensure the appropriate maintenance of relevant documentation.
  • Quarterly AE Review of Clinical Trials - Perform first iteration of listings review, discuss issues with Medical Director
  • Lot Review - Prepare listing and table for Medical Director review and summary
  • Literature Surveillance - Perform review of literature with appropriate documentation; identify case reports as well as new safety information and alert Medical Directors, as appropriate
Clinical Trial Support 25 % of Time
  • Oversee and perform case processing activities working with CTSA to ensure consistency, as needed
  • Investigator Brochure (IB): Contribute to creation, review and updates of IB Aggregate Reports for investigational products such as DSURs, ASRs, IND Annual - collect, collate, format and draft PVRM data contribution
  • IND Safety reports - analysis of similar events - Collect, collate, format and draft data contribution and perform first review
  • Database Lock - Perform reconciliation and signoff
  • Minimum of 4-6 years in a pharmaceutical organization or related industry with a minimum of 2-3 years pharmaceutical experience in a clinical safety or regulatory affairs departments required.
  • Minimum of 2-3 years of medical writing experience (Prefer experience in writing pharmaceutical reports such as PSURs, Clinical Study Reports, safety sections of the ISS and/or Common Technical Document, or white paper) and/or experience in Medical Surveillance and Risk Management.
  • Proven understanding of clinical disease state and implications of treatment.
  • At ease with data and statistics.
  • Proven ability to communicate effectively (verbal, presentation at group meetings, etc).
  • Proven experience with project management (formal or informal).
  • Strategic thinking, organizational leadership, results-oriented performance, team player.
  • Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance (experience with world-wide safety reporting regulations and guidelines) and Risk Management.
  • Excellent interpersonal skills, including ability to work effectively, cross culturally and cross functionally.
  • Excellent written and verbal communication.
  • Master Degree or PhD in Medical Science, Pharmacy or Nursing preferred.
Shiva Prasad | Senior Recruiter
Sunrise Systems Inc.
Desk: (732) 272 0346
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