Role: Drug Safety Specialist
Job Responsibilities
· Screening scientific literature by using the internal search mechanism or by making use of external tools and providers.
· Creating search algorithms for literature screening.
· Performing administrative tasks such as management of contract and user accounts, to up load references and reporting documents into the web system
· To keep track of the internal literature ordering process.
· To create/process ICSRs in cooperation with the Medical Advisors in various data bases and initiate electronic reporting of ADR cases within timeline.
· Documentation of case processing on a company and a case level.
· To cooperate with Medical Advisors in the field of adverse event (AE) and adverse drug reaction (ADR) case processing and reporting
· To assist Medical Advisors in the generation, processing and tracking of follow-up requests.
· Handling of Customer enquiries or complaints according to quality assurance requirements.
· Supportive tasks for Medical Advisors in the scope of periodic reporting (ASR, DSUR and PSUR generation) or other safety- relevant documents.
· To assist Medical Advisors in managing clinical trials.
· To test newly programmed YES applications and/or newly introduced features of YES applications on a validation system for quality assurance purposes.
· To write/review QA documents such as Working Instructions, SOPs, Working Procedures. templates, project metafiles etc. for YES pharmacovigilance projects.
· To perform quality control tasks and other project-specific quality checks.
· Preparation of and participation in internal and external audits/inspections.
Education Background: B PHRAM / M PHARM
Experience: 1-2 Years
Company Profile: Yes Regulatory Healthcare Services Pvt Ltd
Contact Details:
Recruiter Name:
Ms. Babita Chowdhury
Contact Company:
Yes Regulatory Healthcare Services Pvt Ltd
Email Address:
Telephone:
91-11-40563752

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