Manager, Pharmacovigilance Operations
Parexel International Corporation
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.
• 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
QualificationsSkills 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