MSI Pharma are working with a globally recognised pharma company to help source a Senior Director Level Safety Physician to support the Hem-Oncology portfolio. The client are looking for someone with at least 8 years' global safety experience, a strong academic record and clinical medicine experience in an advance medical setting.
As Global Patient Safety lead, you will be responsible for:
- Ensuring all drug safety requirements (including ICSRs, aggregate reports, RSI, NDA/BLA safety-related submission documentation, risk management plans, REMS) needed to satisfy regulatory obligations and support clinical development strategies globally meet standards of quality.
- Serving as primary POC for business lines outside the department for all PV-related activities for the TA.
- Responsible for oversight, planning and management of TA operational and safety science activities and performance.
- Taking a hands on approach to signal detection, processing and mitigation activities as well as leading risk management.
- Providing direction and strategy on process improvements, individual and team interactions and overall TA efficiency.
To be considered for this position you must have:
- Medical Degree (MD or MBBS)
- Board Certification or equivalent in relevant clinical specialty a plus but not required
- 8+ years total experience in Global PV
- Hands on experience in oncology safety, including leading NDA/BLA/MAA submission activities
- Oncology, Hemo-oncology or infectious disease clinical experience a plus
- Significant experience in signal detection, risk management and regulatory submissions/fillings
- Right to work in and be located in the USA