PV Executive for Leading MNC Company based at BKC

Job Description:

Core Job Responsibilities:

• Receipt, recording and reconciliation of safety information.

1. Update the tracker and folder after classification of ICSR by the ASR
2. If applicable, enter the ICSR (Valid/ invalid) in OSYRIS and update the tracker with relevant RCT/LRN/AER number.
3. Keep a track of cases received in OST, share the cases from OST to ASR for review.
4. If applicable submit the cases from OST and update the tracker post submission of cases.
5. For Clinical Trial cases, drafts and tracks submission dossier for regulatory submissions.
6. Ensures correctness and completeness of trackers.
7. Conducts reconciliations with the following stakeholders: QA, MI, vendors, distributors and partners.
8. Update relevant trackers based on reconciliation with regulatory and GPV product list.
9. Reconcile with PSP/MRP program owners for active status and enrollment updates on timely basis.

• Regulatory submission of safety information
• Support in preparation of local periodic safety reports

1. Co-ordinate with stakeholders for gathering of data for PSUR preparation.
2. Co-ordinate with peer reviewers to ensure timely completion of review of draft PSUR.
3. Prepares, track and co-ordinate for submission dossier for PSUR submission.

• PV record retention and archiving

• Drafts and tracks letters for regulatory submissions including PSUR submissions.
• Ensures accurate and complete filing of all PV related documents.
• Ensures archival of all PV related documents.

• Implementation of out-of-office coverage for receiving and recording safety-relevant information
• Maintenance of local PV product list

It will be on the third party payroll of Talisman HR Solutions Pvt Ltd.

interested candidates may sends below details -

Current CTC
Expected CTC

Notice Period

Updated Resume

Reason for Change