Open Positions

Manager, Clinical Drug Safety & Pharmacovigilance

Wellstat Management Company, a privately-held biotech company located in Gaithersburg, MD, is seeking a Facilities/Validation & Calibration Specialist to join our team. The incumbent will provide support in this multi-faceted position in the following areas:

Job Functions:

  • Assess adverse event reports for serious criteria according to applicable SOP, ICH and Federal regulations
  • Research information and compose narratives for case reports
  • Prepare case reports for medical review
  • Ensure that all safety reports are triaged, scheduled, processed and reported accordingly per global requirements and Wellstat SOPs
  • Track cases to completion and adherence to processing timelines
  • Review all clinical study data and medical coding on an ongoing basis
  • Ensure SAE reconciliation between Safety and Clinical databases
  • Review clinical laboratory data for trends on an ongoing basis
  • Conduct quarterly literature searches
  • Responsible for due diligence; i.e., sending medical information requests
  • Review Analysis of Similar Events for SUSARs
  • Communicate with partner companies, vendors, and internal group regarding processing and timely exchange of safety reports
  • Perform and/or provide oversight for day-to-day interaction with DSPV vendor(s) and others, where applicable
  • Represent DSPV in study management teams for assigned products
  • Manage the development and implementation of study Safety Management and Monitoring Plans
  • Oversee reconciliation of safety data with groups external to DSPV (e.g., data management, Business Partners)
  • Participate in workflow development and strategic planning for DSPV
  • Maintain and develop standard operating procedures and work guidance documents, as needed
  • Contribute to DSPV quality management plans and compliance program - assist in DSPV inspection readiness
  • Track compliance metrics
  • Identify and follow-up on corrective action plans arising from audits and inspections related to DSPV
  • Assist in training development program for cross-functional personnel and external groups in drug safety principles and practices
  • May provide and prepare sections of relevant annual and/or periodic reports, as directed
  • Assist study management teams, as needed
  • Perform other duties and projects, as assigned, by company

    Skills/Experience Requirements:

  • 5+ years of relevant Drug Safety / Pharmacovigilance experience in the biotechnology / pharmaceutical industry
  • Excellent knowledge of FDA, EU and ICH guidelines and regulations governing clinical trials and post-marketing safety
  • Proven ability to manage drug safety vendors
  • Knowledge of medical terminology and general principles of clinical assessment of AEs
  • Knowledge of MedDRA dictionary relevant to AE/SAE coding
  • Experience with software-based drug safety systems (ARGUS, ARISg, or equivalent)
  • Strong computer skills (MS Office)
  • Excellent communication and interpersonal skills, including ability to work effectively cross-culturally and cross-functionally
  • Excellent written and spoken English
  • Ability to listen and think critically (sometimes creatively)
  • Experience with CROs and Business Partners, a plus

    Education Requirements:

  • Health care professional (RN, Pharm.D., MD, or equivalent) with, at minimum, 2 years of clinical experience, or Advanced degree in health sciences
  • EudraVigilance certified, a plus

    Wellstat Therapeutics Corporation is an equal opportunity employer and offers a competitive salary and comprehensive benefits package. Please send CV and salary requirements to: Wellstat Therapeutics Corporation, 930 Clopper Road, Gaithersburg, MD 20878, Attn: HR/JV or E-Fax to 301-519-7005 or apply online at

  • Open Positions