Patient Safety/Pharmacovigilance Lead (Flexible Work Location)

Rockville , MD
Apr 23, 2022
May 25, 2022
Full Time
Westat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in Rockville, Maryland, near Washington, DC.

The Patient Safety/Pharmacovigilance (PV) Lead is responsible for providing leadership and oversight for the Pharmacovigilance Unit within Westat's Clinical Trials Practice (CTP). This includes overseeing, managing, and contributing to all aspects of medical surveillance and risk management activities for investigational and marketed products. The Patient Safety/Pharmacovigilance (PV) Lead will be responsible for all activities related to patient safety, PV, signal detection, and medical monitoring. They will ensure the consistency and accuracy of adverse event reporting in clinical studies including initial safety review of adverse events, interaction with safety vendors, review of source documents, and preparation of documents for submission to regulatory authorities. The candidate will manage and develop the safety/medical monitoring plans and team. They will also work collaboratively with internal and external key stakeholders on PV-related matters. 

This position may be hybrid remote or fully remote reporting to management in our headquarters located in Rockville, MD.  

Job Responsibilities: 
  • Ensuring the oversight and responsibility of medical surveillance and risk management activities for teams assigned to a product or therapeutic area. 
  • Managing the medical monitoring activities for all Westat clinical trials.  
  • Contributing to PV aggregate reports (e.g., DSUR, PBRER) and collaborating with PV physicians and key stakeholders to request/receive applicable sections of the report.  
  • Ensuring timely submission to relevant health authorities and other external stakeholders. 
  • Providing training and guidance to other functions within CTP to address ad hoc questions and issues. 
  • Leading the collaboration with the PV physicians to ensure all information is available to allow for informed medical review and benefit-risk assessment investigational product. 
  • Overseeing the technical and scientific support for safety surveillance and signal detection activities for teams assigned product or therapeutic area, including literature review. 
  • Providing safety information as needed for study reports, protocols, informed consents, and Investigator Brochures (IBs). 
  • Leading the collaboration with the PV physicians to ensure all information is available for informed medical review and benefit-risk assessment of investigational product. 
  • Developing Safety Management Plans and Medical Monitoring Plans.  
  • Overseeing the development and maintenance of Risk Management Plans (RMP) and associated pharmacovigilance and risk minimization activities for teams assigned products in conjunction with other internal stakeholders. 
  • Collaborating with internal and external stakeholders outside of PV and establishing effective communication and relationships with them, including PV vendors. 
  • Providing guidance to Data and Safety Monitoring Boards, as applicable. 
  • Taking a leadership role in PV audits and inspections. Participating in audit preparedness activities and serving as subject matter expert during regulatory inspections in collaboration with team members. 
  • Participating in new study initiation to ensure PV requirements are met, such as: safety reporting, query resolution, SAE reconciliation, un-blinding process, and safety reporting training. 
  • Performing timely safety review of adverse events to determine seriousness, expectedness, reporter's causality, and overall event resolution. 
  • Ensuring consistency in the evaluation and assessment of adverse event reports and source documentation for completeness, accuracy, and legibility. 
  • Reviewing safety data output for accuracy and completeness prior to submission to internal and external sources. 
  • Maintaining current knowledge of all applicable drug safety guidelines and regulations (FDA). 
  • Preparing safety documents for submission to regulatory authorities; to be done in conjunction with the Regulatory Affairs Unit and other appropriate CTP members or external collaborators. 
  • Ensuring compliance with clinical protocol safety objectives, policies, processes, and procedures. 
  • Evaluating and improving current processes, as needed, to enhance medical surveillance and risk management to ensure best practices. 
  • Creating new essential SOPs (Standard Operating Procedures) and updating the current SOPs as deemed necessary. 

 In this role you will use your: 
  • Excellent verbal and written communication skills. 
  • Ability to work independently and collaboratively in a fast-paced matrixed team environment. 
  • Analytic thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. 
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.  

Basic Qualifications: 
  • PhD or a medical degree and more than 8 years of experience working in a pharmacovigilance department including at least 1 year of leadership/management experience.  
  • Experience in signal detection, safety surveillance, risk mitigation and risk management. 

Westat offers a well-rounded and comprehensive benefits program focused on wellness and work/life balance. Eligible employees may participate in:
  • Employee Stock Ownership Plan
  • 401(k) Retirement Plan
  • Paid Parental Leave
  • Vacation Leave
  • Sick Leave
  • Holiday Leave
  • Professional Development
  • Health Advocate
  • Employee Assistance Program
  • Travel Accident Insurance
  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • Short Term Disability Insurance
  • Long Term Disability Insurance
  • Life and AD&D Insurance
  • Critical Illness Insurance
  • Supplemental Life Insurance
  • Flexible Spending Account
  • Health Savings Account


Protecting the health and safety of our employees and survey participants is a top priority for Westat. As a federal government contractor, Westat will require Westat staff, regardless of work location, to provide proof that they are fully vaccinated against COVID-19 upon hire and to follow all safety protocols, subject to approved accommodations under applicable law.

Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, creed, color, religion, sex, national origin, age, veteran status, disability, marital status, sexual orientation, citizenship status, genetic information, gender identity or expression, or any other protected status under applicable law.