Medical Reviewer RDV Safety Reporting

Summary of the position :

Alcon is looking to hire Medical Reviewer RDV Safety Reporting.

• Serve as the local subject matter expert for Medical Risk Assessment activities responsible for authoring and safety-related regulatory documentation of marketed products across technology platforms in assigned countries.
• Support and participate in driving department objectives, tool development, and provided recommendations to enhance performance of Medical Risk Assessment activities by working with process stakeholders and teams to align with global and department initiatives where applicable.
• Monitor risk assessment deliverables and activities across technology platforms; escalates potential concerns to Global Device Vigilance management, business process stakeholders, and safety technical platform subject matter experts, and recommends solutions as appropriate.
• Ensure high-quality safety deliverables for all Medical Risk Assessment associated needs.
• Meets internal and external quality standards and achieves required timelines for risk assessment completion to support business deliverables for risk assessment.
• Drafts high quality risk assessments for health authority report submission on or before assigned due date.
• Support continuous improvement initiatives to optimize operational efficiencies and processes for related post-marketing surveillance risk assessment business processes.
• Support audit / inspection questions regarding associated with applicable processes, procedures, and deliverables for processes in scope.
• Establish and maintain working relationships with stakeholders to ensure the fulfillment of applicable post-market regulatory requirements in all applicable activities to risk assessment and deliverables.
• Evaluates and escalates potential risk assessment issues to management and key stakeholders as they are identified.
• Oversees and supports department product training and clinical education training needs through material development develops training material for associates.

Education -

MBBS with emphasis in clinical / surgery and emphasis in Ophthalmology. MD, Ophthalmology experience, Risk Assessment, Trending, Signaling, Research, Clinical. Previous academic experience : Thesis, search, statistical analysis, EUMDR, Alcon product knowledge.

Shift timing - 1pm to 10pm IST

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Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.

Locations - Bangalore - AGS, India