Global Safety Officer - Pharmaceutical

Global Safety Officer

Pharmaceutical

 

The primary function of the CSPU Global Safety Officer's (GSO) role is to identify and effectively manage potential safety issues for compounds under clinical development.

Duties/Responsiblities
1. Review individual safety report for expectedness and causal association
2. Aggregate safety data review & coordinate safety surveillance activities
3. Review Clinical development plan, individual study protocols, SAP, Data monitoring plan
4. Provide scientific overview and contribute to the safety sections of the final study report, Summary of safety of CTD
5. Review and update guidance to the Investigator section of the IDB, informed consent
6. Contribute to relevant sections of the annual IND update and Annual Safety Report
7. Provide pharmacovigilance support to internal/external customers (eg. safety request from authorities/ethics committees, GPE-MPPU, Medical affairs for locally sponsored studies)

 

Knowledge/Skills
Excellent clinical judgment and capability to communicate complex clinical issues in a scientifically sound and understandable way. Previous experience writing complex critical clinical analyses preferred. Demonstrated initiative, ability to formulate investigative plan, capability to work under pressure. Excellent teamwork and interpersonal skills are required.

Formal Education/Experience
M.D. Degree, Board Certified/Board eligible or equivalent preferred with minimum 3 years total experience in international and/or US pharmacovigilance, or equivalent relevant industry experience (eg clinical development). Candidates may be considered if they have proven excellence in a similar position before, even if they have less that 3 years PV experience.

 

Send resume in word.doc

Suzette@sagestaff.com

 

732-974-9600

732-974-9602 FAX