Job Description

Senior Manager PV Scientist
Job Number: 21-04903
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Senior Manager PV Scientist for our client in Summit, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Position Overview:
  • Appropriately perform core signal detection activities and elevate program or portfolio issues impacting key programs, priorities, resources, and milestones with appropriate oversight.
  • Author responses for safety data queries and contribute to specified PV sections of the Periodic Benefit Risk Evaluation Report (PBRER) and Development Safety Update Report (DSUR).
  • Ensure pharmacovigilance regulatory compliance with oversight, as needed.

  • General Product Support:
    • Supports Medical Safety Assessment Physician leading signal detection activities for a product's emerging safety profile.
    • Prepare/write PV sections of aggregate safety documents (eg, DSUR, PBRER) and analyze data for the RSI section of the IB. Write and analyze data for ad hoc responses to health authorities, with oversight.
    • Execute strategy for signal evaluation (eg, case-series, literature review, HA/ claims database).
    • Document signal by Safety Topic Review/ Signal Report.
    • Analyze data and prepare documentation to support label updates for assigned products, with oversight.
    • Support Safety input for regulatory product labeling.
    • Support the EU QPPV or other regional or local Qualified Person for safety issues relating to assigned products.
    • Working knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities.
    • Share with individuals and teams on these applied learnings.
  • Clinical Development & Post Marketing Product Support:
    • Perform core surveillance activities, signal assessment according to the product stage of development for a multiple compounds, with oversight, as needed.
    • Lead Safety Data Review Meetings (SDRM) in the review and evaluation of clinical data to support signal detection.
    • Appropriately elevate issues impacting key activities, milestones, and documents to the Chair with oversight, as needed.
    • Contributes to specified PV sections of the DSURs, PBRERs and safety data query responses to HAs including coordination and integration of input from other functional groups, as needed to support responses to ad hoc queries, with oversight, as needed.
    • Perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data.
    • Executes the strategy for signal evaluation (eg, case-series, literature review, HA/ claims database).
    • Partner with Chair on the evaluation & management of signals emerging from any data source. Authors the Safety Topic Review/ Signal Report and tracks signals for other means of communication, with oversight, as needed.
    • Perform the review and evaluation of SARs for inclusion in the IB RSI, including presentation to ensure alignment.
    • Author the IB RSI table, for less complex products with oversight, as needed.
    • Author documentation to support safety labeling updates to ensure labeling adequately reflects the emerging post marketing safety profile, with oversight as needed.
  • Department Activities:
    • Support preparation for regulatory inspections and audits with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates.
    • Support hiring & orientation.
  • Cross Functional Activities:
    • Support process improvement and cross-functional initiatives for Safety Science including SOPs and Procedural Documents.
    • Builds cross functional relationships with membership and stakeholders
  • Leadership Behaviors:
    • Learner
    • Seeks feedback and best practices for continued development

  • Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent combination of relevant education and professional experience.
  • 3 – 5 years relevant Pharmacovigilance/Pharmaceutical Industry experience.
  • Working understanding of medical concepts and some familiarity with safety activities in drug development and post marketing and global safety health authority requirements.
  • Working understanding of team priorities and milestones. Ability to manage timelines and quality of work using organizational and interpersonal communication skills. Appropriately communicates items that could impact timelines or quality.
  • Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
  • Ability to work well in cross-functional teams.
  • Good collaborative and communication skills with scientific subject matter.
  • Attention to detail along with strong scientific, analytical and conceptual skills and the ability to reach reasoned conclusions.
  • Ability to understand complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, postmarketing reports, scientific literature, and regulatory documents).
  • Understand aspects and methods for data analysis, interpretation and presentation.
  • Possess good working skills in MS Word, Excel and PowerPoint, including statistics
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Paul Quibuyen
Paul Quibuyen | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. 

Application Instructions

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