DUTIES & RESPONSIBILITIES
The Safety Surveillance Physician (Std.) will implement and support further development of proactive and systematic product surveillance strategies, by performing activities such as, but not limited to:
- Performance of alert triage within pre-defined timelines, by conducting systematic reviews of cases and aggregate data in the safety databases and reviewing trends, as applicable, to identify potential safety signals.
- Performance of signal validation and support for signal evaluation through the review, analysis, interpretation, and summary of case and aggregate safety data from various sources such as clinical, post marketing, observational studies, medical literature, health authority databases, and product quality databases.
- Assistance in the development and implementation of strategies for the surveillance of post-marketing data, as well as the development of product-specific medical safety
- Participation as a member of the matrix teams to address product-specific safety
- Support for the evaluation of novel and computer-assisted tools and methodologies for the analysis of safety data.
- Tracking signal disposition and signal management activities in the relevant tracking
- Support for maintenance of documentation relevant to signal detection and management activities
ROLE REQUIREMENTS:
- Must be board-certified medical physician
- Knowledge of Pharmacovigilance (PV) Concepts, regulatory requirements, research principles, and safety data analysis.
- Technical Skills: the ability to analyze, interpret, and present complex data in a concise and understandable scientific manner, both orally and in written format, is essential
- At least one year of clinical experience or experience in pharmaceutical medicine is
- Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) with strong document formatting, data analysis, and presentation capabilities.
- Exceptional Communication and Presentation Skills, with the ability to convey complex clinical and scientific information clearly and effectively to diverse audiences.
- Strong Attention to Detail and a commitment to accuracy, compliance, and quality standards
EDUCATIONAL QUALIFICATIONS:
- Bachelor’s Degree in any Medical Allied Courses is required
- Master’s Degree and/or PHD is a