Job Responsibilities:

Reviews all appropriate safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature).

Conducts medical assessment of all safety related data (AEs, SAE, SUSAR, Argus, etc.).

Ensures medical accuracy of case narratives, coding and medical sense of all cases and ensures appropriate queries are raised to expedite case closure.

Contribute to the development of safety part of clinical protocols.

Provide medical/scientific input into safety reports including China specific safety reports like product safety summary for license renewal, etc.

Writes safety section, including benefit risk assessment of aggregate safety reports such as Periodic Drug Safety Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs) for regulatory submission.

Contribute to the development and maintenance of Risk Management Plans (RMP) from the point of view of a medical safety expert if needed.

Contribute to the development and performance of China Intensive Drug Monitoring program.

Provides safety training to internal employees and external contractors as needed.

Participates in investigators’ meetings to provide training on adverse events reporting as required.

Education, Skills and Experience:

Bachelor of medicine.

2 or more years of relevant pharmaceutical or related experience (e.g. drug safety, clinical development, medical affairs)

Strong orientation towards cross-functional teamwork

Familiar with MedDRA and safety databases is preferred.

Good verbal and written English communication skills.

Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), e-mail, and internet

上班地址：上海市虹口区花园路66弄嘉和国际大厦1号楼16楼