Director, Pharmacovigilance/Safety MD

ROLE RESPONSIBILITIES

  • Organize, manage and actively carry out as appropriate, adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required, local contractual agreements, process documentation and training, inspection preparedness, and any other required safety activity
  • Carry out all case management activities as appropriate
  • Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested
  • Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
  • Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed
  • Consistently apply regulatory requirements and TP Therapeutics policies
  • Analyze and monitor activities, define and implement corrective actions, where applicable
  • Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database
  • Provide oversight and team mentoring on case handling aspects, data extraction and analyses
  • Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and/or project lead across the organization
  • Act as subject matter expert for the DSUR
  • Act as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; and, liaise with key partners regarding safety data collection and handling

QUALIFICATIONS 

  • Education: MD or DVM
  • Experience: Two to three years of clinical research and protocol management experience preferred.

EEO & Employment Eligibility

  • TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com