Sr. Pharmacovigilance Safety Scientist
Location: Fort Washington Pennsylvania
Description: Kaztronix is looking of Sr. Pharmacovigilance Safety Scientist right now, this position will be placed in Pennsylvania. Detailed specification about this position opportunity kindly see the descriptions. Description
TITLE: PHARMACOVIGILANCE OPERATIONS ASSOCIATE II - This position supports the North America Local Safety Officer in oversight of meeting ph! armacovigilance obligations when conducting a Company sponsored/supported program (e.g. clinical trial, market research study, digital/social media program, patient support program, patient registry, investigator initiated study) and is responsible for compliance with global and local regulations and company policies as it pertains to pharmacovigilance obligations. With guidance from the Pharmacovigilance Operations Manager, this position will collaborate with business functions that sponsor/support organized data collection programs that could potentially generate an individual case safety report and with the applicable groups who are responsible for receipt of individual case safety reports. Specific duties include:
With guidance from Pharmacovigilance Operations Manager, interact with study/program managers to ensure obligations related to individual case safety reporting are met
o Evaluate whether a study/program has the potential to generate individua! l case safety reports and document an appropriate plan for col! lection and reporting of individual case safety reports. This includes development of reconciliation process to ensure Company has received any individual case safety report that may have been reported during the program/study.
? Collaborate with groups responsible for receipt of individual case safety reports to ensure that regulatory obligations can be met
o Review program/study tracking system to ensure that tracking points have been correctly populated for each study/program entered into the system
o Provide instructions on training process for Suppliers who require training on identifying and reporting of complaints
? Ensure training material related to identifying adverse events and special reporting situations meets regulatory obligations. Answer queries related to material as required.
o As applicable, ensure that correct contract language related to individual case safety reporting is inserted in Supplier contracts
o Ensure receipt of end of study reports and escalate as appropriate to a medically qualified individual for review when individual case safety reports have been reported as a result of the program/study
o Answer queries about process for meeting individual case safety reporting obligations in organized data collection programs
Monitor Compliance and escalate as appropriate
o Receive compliance data and evaluate for non-compliance. Collaborate with applicable business unit(s) as appropriate to address compliance issue (e.g. implement a corrective action and preventive action plans)
o Escalate non-compliance issues to manager
o Prepare compliance reports when requested that will be reviewed by Local Safety Officer and Qualified Person for Pharmacovigilance
o Support audits/inspections as it pertains to responsible activities
EDUCATION/RELATED EXPERIENCE: Registered Nurse OR Health/Biomedical Degree OR ! Licensed Practical Nurse with Bachelors degree OR Licensed Practical Nu! rse without Bachelors degree. Knowledge of pharmacovigilance requirements is required and is usually exhibited by minimum 5 years experience in pharmaceutical safety related role. Experience with drugs, devices and cosmetics is a plus.
REQUIRED SKILLS/ABILITIES: Accountability for delivery of results Decision making skills Problem solving skills Proactive approach/uses own initiative Managing own work, ability to prioritize, plan and organize work assignments and work under timelines Ability to follow guidelines, working practices etc. Quality orientation, attention to detail/accuracy Flexibility/Adaptability Positive attitude Good team player Ability to work independently and to collaborate Good written and verbal communication skills Navigation of matrix environments Ability to adapt to changing regulatory environments.
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If you were eligible to this position, please email us your resume, with salary requirements and a resume to Kaztronix.
If you interested on this position just click on the Apply button, you will be redirected to the official website
This position starts available on: Wed, 24 Apr 2013 03:21:36 GMT
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