Essential Duties and Responsibilities:
Specialized knowledge and skills:
Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross‑ departmental communication. Ability to document and communicate problem/resolution and information/ action plans.
Desired Technical skills:
Person should be familiar with MS Office Tools.
Extensive knowledge of US, ICH, and EU PV and GCP regulations
Excellent strategic decision-making and analytical skills
Safety database knowledge
The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent timelines.
Awareness of organizational policies & procedures governing his/her job responsibilities. Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/her job level. Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures.
Working Conditions: Normal office environment.
Standard Hours 40 hours per week, one-hour lunch, Monday – Friday. Additional hours as needed.
Willing to work in shifts as and when needed