Drug Safety Associate Safety Officer Quality Control @ Quench Techno Valley

work from home option.
Key Responsibilities:
1. Performing pharmacovigilance activities per project requirement including but not limited to,
2. collecting and tracking incoming Adverse Events (AE); determining initial/update status of incoming events; database entry; coding AE and Products, writing narratives, Literature related activities.
3. Reviewing of ICSR in the Argus database and other case project management activities for assigned clients.
4.Management of compliance with the company standard operating procedures, regulatory and client requirements.
5.Responding to sites and clients queries within appropriate guidelines.
6.Regulatory submissions include making sure that the content is clearly legible and that
7.submissions are properly bound using binders acceptable to the regulatory agency. Also, if any source document is in another language, ensured to provide an appropriate translation.
8.Generate electronic submissions in accordance with regulatory requirements.
9.Assess Lifecycle Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators,oversight groups per legislation, within timelines.
10.Receive, review and process the cases on time, within budget and meet quality standards.
11.Performed regulatory submission, alert letter submission, quality control, assisting with reconciliation and ensure reports are sent to the customer within assigned deadlines.
12. Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities within timelines and in a format compatible to requirement.
13.Source preparation assessment, query reply and other prospective experience in Medidata Rave
14.Clinical trial experience on oncology and vaccine studies, associated pregnancy and fetal case review and processing