Yasini Savandarajan

• Oversaw adverse events case reporting and conducted follow-ups. Individual case safety report (ICSR)
• Review,preparation,and completion of reports of Adverse drug experiences.
• Reviewed and managed regular safety update reports.
• Supported audits as well as CAPAs management as a backup support.
• Reviewed pharmacovigilance procedures.(Malaysian Guidelines on Good Pharmacovigilance Practices-GVP)
• Conducted case reconciliation with internal departments, distributors, affiliates and business partners.
• Trained staff and updated training documents to meet regulations and standards(AEFIs and Reporting Timelines)
• Responded to requests from regulatory agencies and notified to share information.
• Supported PV Lead in maintaining the local PV Training matrix and onboarding plans.
• Supported development and maintenance of local PV controlled documents (i.e., Company Core Pharmacovigilance Documents, training materials, etc. as applicable) ensuring that they are kept current.
• Supported PV self-inspections as required by PV Legislations (where applicable).
• Responsible for completing all required/applicable trainings assigned at time of hire and after hire by the due dates, before performing the activity.
• Supported training of local company staff, distributors, vendors, and business partners as instructed by their manager.
• Responsible for managing and performing local literature screening and assessment in accordance with company procedure and local requirements
• Responsible for Health Authority Website Monitoring for potential safety issues, safety alerts, and new/revised PV requirements in compliance with company procedures and local legislation.
• Responsible for reviewing, providing input and approving local initiatives (e.g., digital interfaces, marketing initiatives/ patient programs, organized data collection systems, etc.), and other programs to ensure compliance with PV requirements.
• As assigned by PV Lead, responsible for scheduling and coordinating submission activities for PSURs and other Aggregate Reports to the local Health Authority in compliance with company procedures and local legislation.
• Responsible for ensuring appropriate implementation and oversight of Risk Minimization Measures and Additional Risk Minimization Measures locally as per department policy and local legislations.
• As assigned by PV Lead, prepare/maintain/submit local RMPs to the local HA.
• Supported local implementation of applicable business continuity plans.
• Files, stores and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
• Served as local Subject Matter Expert on relevant PV regulations, processes, and procedures.
• Represented PV in cross-functional organizational and alliance partner forums as needed.
• Participated on local company committees and councils for matters impacting PV as assigned.

• Daily Task

-Case processing(ICSR)

-PVI case check

-Country Registry Report check

• Monthly Task

-APAC Metrics

-Monthly Safety Report(MSR and ORION)

-Risk Management Plans(RMP)

-Literature Review Search

-Reconciliation(Recon management with vendors)

-Notifiable Safety Scenario(NSS)

-Contract with vendor(Vendor Management and Termination)

-Aggregate Review(PSUR and ORION)

• Quarterly

-Biannual Review(Delta and Biannual)

• Every 6 months

-Bulk Reporting(Batch Report)

Teaching Chemistry and Biology subjects for high school students.

1)Isolation of Bacterium

2)Preparation of Bacterium

3)Micro and Macro-dilution

4)Basic Microbiology Techniques

5)Key in and Transfer Data

6)Plot Graph Using Microsoft Excel