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Job Overview

This role involves applying your knowledge and expertise to review, assess, and process Safety data across various service lines. You’ll be recognized as a specialist in one or more areas, oversee small to medium operational projects, and mentor junior staff members.

Key Responsibilities

• Process Safety data as per regulations, guidelines, SOPs, and project requirements.

• Perform Pharmacovigilance activities, including collecting and tracking incoming Adverse Events (AE)/endpoint information, database entry, coding AE and Products, writing narratives, and more.

• Assess Safety data for reportability to relevant authorities and report within timelines.

• Contribute to or lead deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance, and Medical Information.

• Ensure quality, productivity, and delivery standards are met.

• Build a positive team environment, provide training and mentoring for less experienced team members.

• Provide technical and process information to Safety Management and operational team on project-specific issues.

• Maintain a thorough understanding of project protocol, therapeutic indication, budget, and scope of work (SOW) for assigned projects.

• Attend project team meetings and provide regular feedback/inputs to Operations team manager on operational project metrics, challenges, and successes.

• Contribute to the achievement of departmental goals.

Qualifications

• Bachelor’s Degree in a scientific or healthcare discipline or allied life sciences.

• Up to 4 years of relevant experience, inclusive of up to 2 years of Pharmacovigilance experience.

• Excellent knowledge of medical terminology.

• In-depth knowledge and understanding of the applicable Safety Database and any other internal/Client applications.

• Excellent organizational skills, time management skills, attention to detail, and accuracy.

• Excellent working knowledge of Microsoft Office and web-based applications.

• Proven ability to work independently and autonomously with policies and practices.

• Ability to work effectively on multiple projects simultaneously, organize own workload, and effectively manage teams’ priorities.

• Flexibility to operate in shifts.

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