USA - Medical Director

• Pay: $120-144.53/hr.
• 100% Remote opportunity.
• 6-month assignment with possibility for extension or conversion based on performance and budget.

Responsibilities: 

• Oversight of global medical review of individual case safety reports for Takeda investigational and marketed products from all sources includes but not limited to the following: 
  • seriousness criteria confirmation and expectedness/listedness assessment 
  • review of the reporter’s causality and company causality assessment 
  • event confirmation and coding as per convention, 
  • analysis of similar events as required, 
  • provide sound rationale in Company Comment regarding causality, 
  • ensure due diligence in adequate follow-up, and timeliness of expedited reports 
• Collaboration with other PSPV personnel from other functions (AE processors, safety scientists and Global Safety Leads) in evaluating the safety profile of Takeda products. 
  • Establish with alliance partners harmonization and industry standard medical review and case assessment standards 
  • Ensure effective communication with both internal and external stakeholders on individual case safety assessment related issues and prompt response to the queries 
  • Keep management informed of special concerns and developing safety problems with investigational compounds and marketed products
• Compliance, consistency and timely medical review
  • Ensures complete and timely medical review to ensure accurate and compliant reporting of ICSRs to regulatory authorities globally within regulatory time frames. 
  • Partners with safety operations teams to ensure consistency of work practices and SOPs. 
• Mentoring and training of new and or junior colleagues
  • Work with the Head of Medical Safety Review to implement and augment onboarding and training processes 
• Performs such other duties as requested by management 

Qualifications:

• Medical degree required or internationally recognized equivalent.
• USMLE/ECFMG/COMLEX-USA/FLEX preferred.
• Minimum 10 years pharmaceutical or health care related industry experience required.
• 5 years clinical experience with patients following post-graduate training with significant knowledge of general medicine required. 
• Minimum 5 years experience in Pharmacovigilance including medical review of individual case safety reports required.