Drug Safety Associate - Signal Management
Company: AlphaCure Life Sciences
- Location: Hyderabad, India
- Seniority: Entry level
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
We have a new open position, and the role details are outlined below. Kindly initiate the search process at the earliest and begin identifying suitable candidates for this position. We would appreciate receiving potential candidate profiles within the next week.
Drug Safety Associate - Signal Management (2-3 Years Experience)
We are looking for a Pharmacovigilance professional with 2-3 years of experience in Signal Management, including signal detection, signal validation, signal assessment, and signal tracking activities. The candidate should have hands-on experience in reviewing safety data from multiple sources (ICSRs, literature, aggregate reports, etc.) and preparing signal evaluation documentation. Experience with pharmacovigilance safety databases, data mining, trend analysis, disproportionality analysis, aggregate safety data review, and benefit-risk assessment is required. Knowledge of GVP Module IX, FDA/EMA signal management requirements, and strong analytical and communication skills are preferred.
