Drug Safety Manager require at Covance | B.Pharm

Covance is one of the world’s largest and most comprehensive drug development services companies with more than 11,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

Post : Mgr Drug Safety

Job Description
Key Competencies
• Experience in managing operations and offshore delivery
• Experience in managing performance
• Experience in transitioning processes
• Strong people management and leadership skills
• Excellent verbal and written communication skills
• Focus on quality
• Coaching and mentoring skills
• Knowledge of quality management frameworks such as Six Sigma
• Ability to engage with the client and support account mining activities
• Planning and prioritizing
• Proactive risk identification and management Key Accountabilities Strategic
• Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
• Ensure compliance of operations with governing regulatory requirements
• Create, maintain and assume accountability for a culture of high customer service
• Ensure delivery of services meets or exceeds Service Level Agreements

Operational
• Create and execute project work plans and revises as appropriate to meet changing needs
• Identify resources needed and assigns individual responsibilities
• Manage day-to-day operational aspects of a project and scope
• Review deliverables prepared by team before passing to client
• Enforce project standards
• Prepare for engagement reviews and quality assurance procedures
• Ensure project documents are complete, current, and stored appropriately
• Resolve and/or escalate issues in a timely fashion
• Facilitate team and client meetings effectively
• Hold regular status meetings with project team
• Track and report team hours and expenses
• Manage project budget
• Analyze project profitability, revenue, margins, bill rates and utilization
• Identify business development and "add-on" sales opportunities as they relate to a specific project/client
• Lead proposal efforts including project scoping and effort estimation

Candidate Profile
• 6+ years’ experience in pharmaceutical industry / Regulatory Affairs /Quality Assurance / related services
• At least 2+ years’ experience in managing projects & leading a team (people management)
• Excellent understanding of pharmaceutical product development cycle
• Extensive knowledge of guidelines and regulations pertaining to regulatory submissions for US, EU and emerging markets
• Excellent Knowledge of regulatory procedures for product approval and maintenance/
• Excellent Knowledge of Good Manufacturing Practices
• Technical proficiency with Microsoft Office suite of applications and Document Management and publishing tools

Additional Information
Experience : 8-12 years
Qualification : B.Pharm
Location : Mumbai, India
Industry Type : Pharma / Healthcare/ Clinical research
Job ID : 47481
End Date : 15th October, 2020