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Principal Scientist, PVRM
Ref No.: 17-14045
Location: Marlborough, Massachusetts
Principal Scientist, Pharmacovigilance and Risk Management (PVRM)
Summary: The Principal Scientist reports to the Medical Leader as part of a team that performs high quality and timely scientific and operational analysis of pharmacovigilance information. This position works closely with the Safety Systems & Information Management and Strategic Alliance, Compliance & Training groups as part of a matrix team to support the Therapeutic Area business unit by ensuring that pre- and post-marketed products are adequately supported from a safety standpoint.
Responsibilities:
In conjunction with Medical Director, perform safety surveillance activities within a product(s) team that include:

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

Risk Management/Post-Approval Commitments. 10 % of Time
  • Under supervision of the Medical Director, contribute to creation, annual review and update of RMPs as needed.
  • Follows up on safety related post-approval regulatory commitments for assigned products

Aggregate Reports 10 % of Time
  • PSURs
  • Draft/Collect Sections 1 through 8
  • Work with others to determine topics for discussion in Section 9; prepare first draft of Section 9 for Medical Director review
  • Follow-up on issues identified in regulatory responses (e.g., assessment reports)
    US Periodic Reports – Obtain data and develop first draft


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


Regulatory 10 % of Time
  • Regulatory Requests/Responses - Pull data and draft response in consultation with Medical Director prior to management review
  • Submissions - Contribute to creation and review of 2.5, 2.7.4 of CTD; Integrated Summary of Safety; proposed labels for submissions
  • Manage pharmacovigilance related activities associated with proposed safety label changes
Other 5 % of Time
  • Effectively manages department workload and product responsibilities.
  • Manage respective outputs for assigned product(s) ensuring on-time delivery of quality documents. Ensures timely decision-making, problem solving, follow through and appropriate managerial elevation of issues.
  • Represents functional area on routine issues and facilitates multidisciplinary communications
Experience/Requirements:
  • Master Degree or PhD in Medical Science, Pharmacy or Nursing preferred.
  • 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.