Job Summary:
We are seeking a highly motivated and detail-oriented physician to join our growing Drug Safety & Pharmacovigilance team as a Director of Medical Safety. In this role, you will play a key function in ensuring the safety of our marketed drugs and contribute to the development and implementation of pharmacovigilance activities in accordance with regulatory requirements.
This position is a part-time (50%) and 6-month contract position. We are open to candidates in the US, UK, or Europe who are available to work during EST or UK hours.
Responsibilities
* Perform signal detection activities to ensure signal identification and evaluation, including individual and aggregate data analyses, interpretation of safety signals and trends, and documentation and communication of safety assessments for all company medicinal products
* Participate in safety surveillance strategy and activities for all Autolus investigational products
* Conduct medical review of individual case safety reports for post-marketing adverse event reports
* Contribute to the creation of analysis of similar events
* Collaborate with partners on safety monitoring and signal detection and risk management activities
* Collaborate, contribute to and review relevant sections of clinical and regulatory documents, including protocols, informed consent forms, study reports, integrated summaries of safety, expedited safety reports, DSURs, PBRERs marketing applications and other regulatory submission documents on assigned projects
* Contribute to the creation and maintenance of Reference Safety Information (RSI), safety sections of Investigator Brochures (IB), and Company Core Data Sheets (CCDS) for all investigational and marketed products
* Review and summarize scientific literature relevant to pharmacovigilance
Qualifications
* MD or equivalent with 5+years of drug safety experience (with 5+ years managing medical case review and signal detection)
* Must have experience in Oncology
* Strong knowledge and understanding of international safety reporting and pharmacovigilance requirements and signal detection
* Ability to take initiative yet work collaboratively on multiple projects and with partner companies to achieve goals in compliance with PV and regulatory requirements and safety data exchange agreements
* Excellent written and oral communication skills
* Excellent interpersonal skills and ability to work effectively as part of a team(s)
* Experience in drug development desirable