Pharmacovigilance

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Job Function:
Product Safety

Job Sub Function:
Pharmacovigilance

Job Category:
Scientific/Technology

All Job Posting Locations:
Kibbutz Shefayim, Center District, Israel

Job Description:

General Job Duties and Responsibilities



* Ensure that the local Pharmacovigilance (PV) system is managed in compliance with local regulations and company policies/procedures at local, regional, and global levels and in accordance with any PV agreements with third party business partners.



* Ensure compliance with own training curriculum



* Be an ambassador of the Local Medical Safety mission and vision



* Participate in or lead LMS projects and initiatives at local, regional or global level

ICSR MANAGEMENT AND OVERSIGHT



* Ensure local collection, review, reporting, reconciliation, and follow up on Individual Case Safety Reports (ICSR).



* Manage and maintain active involvement in day-to-day ICSR management related activities as applicable.



* Ensure implementation of local literature process.



* Maintain oversight of corresponding vendor activities as required.

COMPLIANCE ACTIVITIES



* Ensure PV audit/inspection readiness at the LOC level at all times.



* Maintain oversight of ICSR inbound and outbound compliance.



* In cooperation with Medical Safety Quality (MSQ), perform ICSR reconciliations
and review compliance dashboards from MSQ for accuracy.



* Increase PV compliance awareness and business relevance with stakeholders and
ensure appropriate ownership of PV-related findings and Corrective Action/Preventive Actions (CAPAs).



* Escalate compliance issues in a timely manner to Country/Cluster Safety Head (CSH),
to ensure appropriate mitigation is implemented.



* Address follow-up actions from Local Safety unit (LSU) owned non conformances,
including LSU related CAPAs

AGGREGATE REPORTING


* Review, translate (if applicable), prepare, submit and track aggregate reports as required by local regulations
and ensure compliance oversight requirements are met



* Support the preparation of aggregate reports and provide due dates to Global M...