1. Position Overview
Drug Safety Physician is primarily responsible to perform ICSR medical review and related activities.
2. Key Duties and Responsibilities
- Perform medically sound evaluation of adverse event reports, including assessment of seriousness, listedness/expectedness, and causality of individual case safety reports according to applicable guidelines, standard procedures, and product-specific relevant safety information.
- Analyze safety data and utilize appropriate signal detection tools to identify, assess, and validate safety signals for assigned products.
- Perform data-driven analyses of safety data to derive relevant and practical insights pertaining to product safety.
- Maintain intimate familiarity with, and keep abreast of any updates to, the labelling information and safety profile of company products.
- Maintain updated knowledge of global regulatory guidelines and local procedures and apply as appropriate to all safety activities.
- Participate in initiating effective and efficient guideline- and process-compliant solutions towards achieving product safety monitoring goals.
3. Qualifications
- At least 2 years clinical experience in medicine.
- Excellent oral and written English communication and presentation skills.
- Strong attention to detail, with ability to provide consistent high-quality work in a deadline driven environment.
- With valid professional license for Physician to practice medicine locally.
4. Skills required
- Excellent spoken and written in English
- Multi-tasking and flexible to operational requirements
- Displays strong leadership, communication, and analytical skills
- With strong ethical standards
- Must have strong initiative and sense of urgency
- Proficient in MS Office
5. Education : Doctor of Medicine
6. Primary Location : Bonifacio Global City, Taguig
7. Contact Detail : [Confidential Information]
