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Principal Scientist, PVRM
Ref No.: 18-06736
Location: Marlborough, Massachusetts
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
See attached JD for more information.

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.