Drug Safety positions in PA!

Kelly Clinical Resources is seeking a Drug Safety Associate to work in PA. As a Drug Safety Associate you will be encompassing the processing and monitoring of adverse event reports for investigational and marketed products following company Standard Operating Procedures to ensure compliance with worldwide safety regulations, corporate and regulatory guidance documents, and corporate policies.
Qualified candidates must experience with serious adverse event reporting and prior litigation experience.
PRINCIPAL RESPONSIBILITIES

Evaluates adverse event reports, assesses regulatory status which is seriousness and expectedness/relatedness in order to prioritize workload.
Processes adverse event reports from clinical trials and from marketing activities as per company Standard Operating Procedures and guidelines for maintaining regulatory compliance.
May perform risk and quality function on adverse event reports including manual coding as needed.
May request Quality Assurance analysis on appropriate cases according to SOP. May also perform Monthly Reconciliation with Centers of Excellence.
May determine need for and request follow-up using appropriate communication methods (eg. fax, email, telephone or site visit).
Participates in team discussion for both processing and product knowledge.
May provide coverage to other therapeutic teams as needed.
May prioritize workload for product(s) and liaise with other Safety Associates to ensure timely processing.
May mentor Safety Coordinators/Sr. Safety Coordinators/Safety Associates.
Performs other related duties as required. This may include preparation of US periodic reports, review of literature to identify cases or reconciliation of SAE's between clinical and safety databases. May be involved in the unblinding of clinical cases.Kelly Scientific Resources is one of the many divisions under Kelly Services. Kelly Scientific Resources (KSR) provides staffing services on temporary and full time project based positions. KSR works on positions in industries such as Biomedical, Clinical Research and Pharmaceutical. Kelly Services is a fortune 500 company and an equal opportunity employer.




job Requirements


Please refer to the job description above.