[1] Pharmacovigilance Area 

1. To carry out PV activities in a proper and timely manner in accordance with the relevant regulations, SOPs and Code of Practice. 
2. To report and manage Individual Case Safety Reports (ICSRs) for investigational and marketed products to the headquarter, partners and the regulatory authority within the required timelines. 

-        Receive and triage of ICSRs;
-        Track and file ICSRs;
-        Communicate for ICSRs; 
-        Conduct ICSRs reporting;
-        Follow-up on additional information;
-        Handle ICSRs-related inquiries;

1. To collect adverse events of investigational & marketed products and safety issues from various sources (e.g. literature, MIS query, media, HCP, patient, clinical study and etc.).
2. To  communicate with the regulatory authority and the headquarter for safety issues properly. 
3. To monitor regulatory changes related to PV in a timely manner and take appropriate actions to cope with the changes by analyzing their impact on the business.
4. To co operate  with RA for  handling product complaints and safety related issues regarding labeling changes.  
5. To collaborate with relevant parties for global and local clinical trials (e.g. safety related document review, SAE reconciliation and SAE flow plan). 
6. To prepare and maintain PV agreement with co-promotional companies and to ensure their compliance with PV. 
7. To prepare and execute the Risk Management Plan (RMP) properly.
8. To conduct and/or support active surveillance (e.g. PMS) as part of the RMP.
9. To prepare and submit aggregated reports (e.g. PSUR/PBRER, DSUR) in a timely manner.
10. To prepare safety data for product renewal.
11. To conduct or support PV training for all employees in a timely and efficient manner.
12. To support or manage the product liability issues.  
13. To develop and maintain relevant SOPs for PV activities in accordance with global/Asia regional SOPs and regulations.
14. To manage PV system and data.
15. To collaborate with the headquarter and relevant functions like MR, MKT, MIS and IT for PV activities. 
16. To perform other miscellaneous administrative tasks

[2] COMPETENCIES:  

1. Good understanding of regulation regarding safety reporting
2. Good ability in working according to global standards
3. Good written and spoken English capabilities 
4. Good knowledge of computer software 
5. Good interpersonal skills and communication skills 
6. Good collaboration skills □     Good presentation skills
7. Good conflict management skills 
8. Good change management skills 
9. Good time management skills 
10. Problem-solving skills
11. Ability to give prioritize tasks 
12. Active and open-minded person to handle multi tasks in the department 
13. Professional and positive attitude 
14. Have strong agility for the self-motivation/development to be a member of high- performing team 

1. Requirement: At least 3 years of experience in PV or related area
2. Preferrence: Masters/Bachelors level degree in health science, pharmacy and Nursing etc.