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Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting With Heart®? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people With Heart®.

Manager, Pharmacovigilance Operations

Job ID 74367BR Romania - Any Region - Home Based
As a Pharmacovigilance Operations Manager you will manage and supervise project’s PV Operations staff on a day-to-day basis, guiding performance of PV Operations staff in ongoing projects in terms of quality of deliverables, compliance with the timelines and relevant trainings. You will also provide process-related expertise for the various project specific activities including but not limited to processing of Individual Case Safety Reports, Signal and risk management, Regulatory operations and Medical writing, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs) and communicate with client for queries/feedback.

Key Accountabilities:
• Providing functional expertise/oversight of process and handling queries of the PV Operations staff
• Participation in meetings with client and within team, as needed.
• Performing activities delegated to the PV Operations staff in case of unplanned peaks or urgent requirements
• Prepare for and respond to internal/external audits/inspections
• Taking suitable action as per client feedback for any performance or process related concerns
• Providing project updates to the Senior Management on periodic basis
• Assisting his/her manager for operational day-to-day activities
• Maintaining up-to-date knowledge of relevant regulations and client’s and Parexel’s Standard Operating Procedures
• Coordinate with Solutions Consultant and/or regional Head of PV Operations as appropriate to assign resources to the project, and to assess staffing needs for current and future activities
• Ensuring to meet the requirements as in-Service Level Agreements and achieving all defined and agreed Key Performance Indicators in terms of quality, compliance and trainings


Skills and Experience required for the role:
• Degree in life Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.).
• A degree in Medicine/Dentistry/physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage.
• Considerable drug safety knowledge and experience
• Excellent knowledge of drug safety and the drug development process, and ability to interpret and apply global safety regulations
• Excellent team / project leadership and delegation skills, ability to train and mentor people
• Fluent English verbal & written
• Experience with computer applications including database management and Pharmacovigilance related computing systems

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