Associate Director, Drug Safety Physician
RTP Area, North Carolina
We partnered with an industry leading CRO in their search for an Associate Director Drug Safety Physician to join its rapidly expanding team. This organization has grown dramatically over the course of the past 5 years and this newly created role is a direct reflection of that continued growth. This position is extremely fast paced and will allow you to broaden your horizons across a wide range of therapeutic areas. This opportunity also provides a clear path for growth into a director level position down the road. If you are looking for a role that will accelerate your career in PV/ Drug Safety than do not hesitate to apply!
The Associate Director, Drug Safety Physician will have the following responsibilities:
- Ensure that all pharmacovigilance obligations are fulfilled and that all the required PV activities are in line to support a clinical trial
- Perform medical review of individual case reports from clinical trials. Overall responsibility for assessing expectedness and company causality in a timely manner
- Medical follow-up of clinical trial cases with the investigators for missing/clarification of safety information in a timely manner
- Prepare or review Safety Management Plans (SMPs), Reconciliation Plans and other safety-specific plans in liaison with clinical development teams and CROs
- Provide medical guidance to assigned projects and other departments on clinical expertise matters.
- Provide Scientific input/review of: clinical study protocols, clinical study reports, Investigator Brochures, case report forms for global bioequivalence & clinical endpoint studies
- Maintain safety profile of sponsor's products in development in liaison with clinical leads. Periodic review of SmPC/USPI review of brand leader products for changing safety information
- Maintain up-to-date knowledge of global HA/ethics expedited and periodic submission requirements and train clinical safety team members as necessary
Ideal candidates will have the following skill set:
- Medical Degree
- 2+ years' experience in PV/ Drug Safety
- Experience working in a CRO environment