Job Description:
- Review, assess and process safety data and information on timely and accurate manner received from various sources and distribute reports/ dates internally and for regulatory agencies in local and regional setting.
- Determine initial / follow up status of incoming events.
- Assist in the preparation of pharmacovigilance documentation for regulatory submission, including periodic safety reports and risk management plans.
- Perform Pharmacovigilance activities as per product categories requirements including but not limited to, collecting and tracking incoming AE / endpoint information.
- Assist in the preparation of medical information materials and providing support for medical inquiries.
- Participate in the development and delivery of pharmacovigilance training programs for internal staff and external stakeholders.
- Work closely with Medical Scientific Affairs department to perform and follow up causality assessments for reported adverse event (AE).
Minimum Qualifications:
- Degree holder in Pharmacy, Life science or equivalent experience.
- Familarity with coding dictionaries (MedDRA) is a plus.
- Strong attention to details.
- Excellent communication and interpersonal skills with ability to work collaboratively and influence cross-functional team.
- Able to converse in proficient Chinese.
- Strong verbal / written communication skills.
- Able to follow instruction/ guidelines, utilise initiative and work independently.
- Experience in case processing, safety reporting and risk management activities.
- Able to multitask, manage competing priorities and deadlines in fast paced environment.
