Ref #: 25128

Employment type: Permanent - Full-Time

Location: Taipei, Taiwan

Posted: 12-Nov-2020

Description

Position Summary:

- Technical/Administrative support to local DS&E team in activities such as preparation of documents for further processing, review, expediting and final archiving.
- To support DS&E operational processes at Country Pharma Organization (CPO) in ensuring compliance with global/local procedures, national and international regulations/ standards/guidelines for pharmaco-devicevigilance of marketed and investigational products
(drug and devices).

Responsibilities:

The responsibilities of the Senior/Drug Safety Associate may include, but are not limited to:

1. Prepares the respective submission documents to Health Authorities.
2. Supervise of proper flow of confirmations of receipt of documentation sent to the Health Authorities.
3. Prepares and distribute of respective DS&E documents externally.
4. Participates in the verification process of data correctness in the global safety database.
5. Verifies the correctness and compliance of documentation sent to CPO DS&E Department:
* Internal documents translation
* Verification if a document sent to DS&E grant the safety requirements of the internal materials as described in respective company procedures.

6. Prepares the CPO DS&E training materials (incl. confirmations) and logistic organization of these trainings
* Editing (where required and as per request from CPO DS&E Member) training materials
* Preparation of confirmations, certificates, printing of training materials for participants

7. Archives all safety documentation as per respective policies, guidance and procedures.
8. Monitor the compliance with support of the functional/Operational manager
9. Verifies and update of respective CPO DS&E archiving system (incl. review, update, management)
10. Manage collection, documentation, triage, translation (if applicable) processing in company Safety Database, transferring to Central Processing sites (if applicable), follow-up, submission/distribution to local health authorities or ethic committees (if applicable) and archiving of all safety reports for all company products (drugs and devices) from pre and post-authorization (as applicable) phase according to the defined timelines and quality parameters.
11. Work with other local/global PVO associates to ensure accurate evaluation of safety data.
12. Interact and exchange relevant safety information with LHA, PVO associates, other functional groups and third party contractor, if applicable.
13. Monitor for any pharmacovigilance specific regulatory changes at country level and inform the Drug Safety Responsible/Drug Safety Responsible Deputy for further global communications.
14. Support in set up, implementation, keeping accurate and maintenance of the local DS&E procedures as per company Pharmacovigilance procedures and national requirements.
15. Liase with program owners and provide advice to ensure appropriate mechanisms to collect, report, manage and reconcile safety information as well as appropriate adverse event training to the third party companies involved.
16. Perform reconciliation with departments at company that may receive adverse event/special case scenario reports (e.g. Medical information, Quality Assurance, Sales force/Marketing, Legal, etc).
17. Management and maintenance of all relevant CPO DS&E databases.
18. Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed.
19. Ensure reporting and follow up of all spontaneous adverse events (AE) and technical complaints for all comapny products according to respective SOP.


QUALIFICATIONS:

- Secondary Education/ Health Care Sciences Professional

EXPERIENCE & SKILLS:

- Certified level of written and spoken English
- Good working knowledge of local language
- Experience on similar position in drug safety or drug registration or clinical research department would be an additional asset.
- Quality and focus oriented.
- Computer technical skills (e.g. Excel, Word, Power Point).