General Information

Location: Plymouth Meeting, PA

Organization: Trifecta Clinical

Job Type: Full Time - Regular

Description and Requirements


WCG’s clinical solutions are built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those who perform clinical trials. WCG is proud to serve the individuals on the frontlines of science and medicine, and the organizations that strive to develop new products and therapies to improve the quality of human health. It is our role to empower them to accelerate advancement, while ensuring that the risks of progress Never outweigh the value of human life.

At WCG, our employees are our most asset and as with all our assets, we invest in them with an eye toward future success. We provide each eligible employee with a comprehensive set of benefits designed to protect their personal and financial health and to help them make the most of their future.

  • Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts
  • Employee Assistance Programs and additional work/life resources
  • Referral Bonuses and Tuition Reimbursement
  • Paid time off including holidays, vacation, and sick time
  • Opportunities for career development with on-the-job training, certification assistance and continuing education reimbursement

JOB SUMMARY:  

The Pharmacovigilance Services Manager is responsible for the AE/SAE workflow of the cases and the smooth running of the safety system, accurate and timely case processing tasks, writing of procedures, client specific Management Plans, and other documents. This position oversees Case Intake and Triage, oversees the safety systems including updates, instance procurement and configuration, design of custom reports, performs clinical trial reconciliation, line listings and metric reports.  . 

Vaccination Requirements:

To be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date.

Education Requirements:
  • BS/BA in Nursing or healthcare related field or PharmD or licensed certification as a healthcare professional. 

QUALIFICATIONS/EXPERIENCE: 

  • 5+ years of experience in a CRO, Pharma or Biotech safety department 
  • 3+ years of clinical or post-approval pharmacovigilance related experience 
  • Strong  understanding  of  industry  standard  clinical  trial  safety  and/or  post-marketed pharmacovigilance/device vigilance processes and regulations
  • Demonstrated hands-on experience and solid knowledge of safety databases, data entry platforms, adverse event data collection processes, medical information and adverse event data collection processes, medical information and adverse event call center processes, and/or product quality complaint processes 
  • Strong knowledge of system updates, configuration, and coding 
  • Strong knowledge of Good Documentation Practices (GDP), Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP) 
  • Solid knowledge of drug safety related ICH Guidelines, FDA 21 CFR 312.32, 314.80 and MedDRA and WHO drug coding 
  • Demonstrated  knowledge  and  experience  with  safety  reporting  and  regulatory  compliance; experience with international safety reporting/regulations 
  • Strong attention to detail and accuracy in work output 
  • Strong teamwork and collaboration skills 
  • Ability to persevere in a fast-paced work environment. 
  • Flexibility to adapt to changing work priorities and manage competing priorities. 
  • Strong interpersonal and written and verbal communication skills. 
  • Customer service orientation towards internal and external stakeholders 

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successful y, an individual must be able to perform each essential duty and responsibility satisfactorily.  The requirements listed below are representative tot he knowledge, skills, and/or ability required. 

  • Oversees centralized intake center for the receipt of safety event reports, data entry and administration and provides hands on support.  Assures specific data and quality targets for case/inquiry handling and tracking are maintained 
  • Assists with the set up and oversight of medical information inquiries, fulfillment, and product quality complaint (PQC) management and report transfers as required.   Interacts with other vendors or client staff to assure a smooth process is maintained 
  • Manages the workflow and assures priorities and timelines are followed by the Team(s) 
  • Organizes workload to ensure compliance with Safety Data Exchange Agreement (SDEA) and other global regulatory reporting requirement for ICSR. 
  • Performs quality review of reports. 
  • Oversees the case suppression process for invalid reports including hands on support 
  • Oversees the preparation, processes, distribution and tracking of regulatory submissions 
  • Identifies cases requiring investigator alert reports, oversees the drafting of the alert letter and the distribution process. 
  • Performs clinical trial reconciliation, creates line listings and custom reports 
  • Prepares training materials and trains new employees or existing staff on new projects  
  • Oversees and manages systems updates, installations, and upgrades for all safety system technologies from a business aspect.  Assists and oversees system validation and testing.  
  • Leads system related projects with system vendors and assures al  project steps are performed and documented 
  • Other duties as assigned by supervisor. These may, on occasion, be  unrelated to the position described here. 
  • Attendance and punctuality are essential functions of the position. 
Expected annual base salary range: $77,600 to $108,500

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