Director, Patient Safety

Less than 5 years experience  • 

Salary depends on experience
Posted on 04/18/18
Santa Monica, CA
Less than 5 years experience
Salary depends on experience
Posted on 04/18/18

Job Description

We are seeking a highly motivated individual to join us as a Director, Patient Safety.  You will work with the Clinical Development team in supporting our efforts in this exciting new area of cancer immunotherapy. 


Responsibilities (include but are not limited to):

  • Medical safety expert for product candidates
  • Oversight of clinical trial safety including safety monitoring plan and data analysis
  • Assess emerging safety data, ensure appropriate risk communication, and development of risk management/minimization strategies
  • Respond to queries relevant to the safety of products from the agencies and other internal functions
  • Provide review of clinical protocols and study reports to ensure alignment with Clinical development plans and safety being adequately addressed.
  • Carry out medical review of Serious Adverse Event reports from clinical trials.
  • Contributes to the safety section of the Investigators Brochure (IB)
  • Contribute to regulatory authority submissions (e.g. NDAs,) by reviewing safety data and preparing relevant sections of the submission
  • Aggregate safety reports, safety aspects of regulatory filings

Requirements:

  • MD or equivalent degree; completion of residency
  • 3- 5 years of industry experience in safety and pharmacovigilance; oncology experience required
  • Global experience in clinical trial as well as post-marketing setting
  • Global regulatory filings
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Good knowledge of US and EU pharmacovigilance regulatory requirements
  • Ability to function in a matrix organization
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
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