HireDiversity

Beijing, CN

Medical Safety Scientist-000008ZK

Description

- Medical evaluation of individual adverse event case safety reports, including but not limited to all serious and expedited reports
- Accountable for clinical safety review, recommendation and interpretation, analysis and summarization of aggregate safety data and periodical data from all sources including spontaneous, clinical, post-marketing and observational studies, literature review and product quality (e.g. safety summary and regulatory inquiry etc)
- Provide therapeutic area/pharmacovigilance issue and guidance in single case assessment;
- Participate labelling review activities and meetings for execution of pharmacovigilance components of Risk Management Programs and related activities including assessment of potential signals;
- Participate as core members of pharmacovigilance responsible for pharmacovigilance activities focused on individual products and pertinent therapeutic areas;
- Responsibilities include training activities, contributing to the development and implementation of risk minimization action plans etc.
- Assist/present in the preparation and review of ad hoc reports pertaining to safety-related matters;
- Assist in the review of literature publications following established procedures for safety reporting purposes;
- Ad hoc to ensure due diligence in supporting decision making and characterizing adverse events

Qualifications


1. Degree/Advanced degree in clinical medicine or pharmacy, appropriate post-medical degree / specialty accreditation strongly preferred

2. Drug safety experiences in PV or clinical research or drug development in international pharmaceutical companies at least 4-6 years

3. Good problem solving and decision making skill

4. Strong interpersonal skills, with a demonstrated ability to foster team work

5. Ability to manage discussions and decision making

6. Excellent communication, conflict management and negotiation skills

7. Good English/Chinese communication skill (written and verbal)

8. Opening, optimistic and easy going personality

9. Good computer application skills.

Primary Location:Asia Pacific-China-Beijing-Beijing
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Job Function: Drug & Product Safety Operations