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Thursday, August 26, 2010

Drug Safety Associate

DesignationDrug Safety Associate
Job DescriptionResponsible for complete and accurate data entry of Adverse Event cases to achieve the service level agreement.
Responsibilities/Authorities :
 Prioritise Data Entry activities for Cases by reference to the Date of Receipt in accordance with SOPs and Guidelines;

 Data entry of safety information, including relevant medical history and laboratory data and therapy dates into the applicable Global Safety Database in accordance with Guidelines and SOPs;

 Validate data consistency and make any corrections as needed;

 Submit to Case Safety Reports for scientific and medical evaluation;

 Review responses to queries when received and update the Global Safety Database as required;

 Document any amendments to the Data Entry Conventions and agree these with the client Functional Lead, prior to their implementation;

 Participate in clinical study reconciliation activities, as requested by client; and

 Issue reconciliation listings as requested by client to the relevant Connected Entity and to client

Desired Profile Knowledge of coding applications, databases, processes and tools is preferred;

 Experience in researching information utilizing available resources including publications and the World Wide Web;

 Effective communication, organisation and time management skills;

 Good interpersonal skills and the ability to operate effectively in an international environment;

Experience0 - 1 Years
Industry TypePharma/ Biotech/Clinical Research
RoleClinical Research Associate/Scientist
Functional AreaHealthcare, Medical, R&D
EducationUG - B.Pharma - Pharmacy
PG - Any PG Course - Any Specialization,Post Graduation Not Required
Compensation:Rupees 50,000 - 1,50,000
KeywordsMs office ,Data Entry ,Clinical Research
Contact.Roopa Shankar


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