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Lead Drug Safety Specialist
2 weeks ago
We are seeking a highly skilled professional to oversee the drug surveillance program, encompassing follow-up and risk assessment for adverse reaction reports. This role requires expertise in clinical trials and pharmacovigilance to ensure safety in post-marketing programs.
The ideal candidate will provide trending and safety signal detection, as well as risk management assessments throughout the product life cycle. They will also support clinical development teams with medical information and literature review.
- Monitor the clinical safety of projects/products, evaluating individual cases or signal detection, and responding to safety-related questions appropriately.
- Perform medical assessments and related activities, including collecting additional follow-up information, medical evaluation of product quality defects with adverse events, and preparation of investigator notifications.
- Identify safety signals based on review of solicited or unsolicited single cases.
- Perform signal detection, monitoring, and evaluation of all safety signals.
- Provide inputs into responses to inquiries from regulatory authorities or healthcare professionals on safety issues.
- Prepare safety data for Health Authority review boards.
- Provide expert evaluation on the clinical context of adverse event reports and implications on products.
- Collaborate with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, and other departments.
- Contribute to departmental goals and objectives.
- Timeliness and quality of safety analyses, interpretations, and presentations - Compliance with internal and external regulations and procedures - Compliance, consistency, and quality of safety deliverables