Job Description:
For over 25 years PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, we supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. We have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world. For more information about PAREXEL International visit www.PAREXEL.com .

The Line Manager PV Ops will:
' Line manage and supervise regional Drug Safety staff on a day-to-day basis, guiding performance of Drug Safety staff in ongoing projects in terms of quality of deliverables and compliance with the budget
' Study Assignment to Drug Safety staff based on previous experience workload and availability
' Provide own technical and process-related expertise to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).

Key Accountabilities
Line Management Responsibilities
' Assign Drug Safety staff to projects upon request of Medical Business Operations (MSE/NAMS) and delegate work to Drug Safety staff according to allocated budget/hours
' Cooperate with Senior Medical Director-RTP and/or Medical Business Operations as appropriate to assign resources to new projects, and to assess staffing needs for current and future projects
' Ensure that the work provided by the Drug Safety staff is in accordance with the hourly budget provided by Medical Business Operations
' Review timesheets and T.I.M.E. utilization reports and provide input into monthly reports
' Assist Regional Head of Medical Services/Head of PV Ops in interviews for recruitment of new personnel and in termination of employment as necessary
' Organize, in conjunction with local QPT staff, mentoring and training (general and on-the-job) for new staff and ensure continuous training within the department and with other departments, where appropriate
' Perform annual appraisals of Drug Safety staff, and provide recommendations for promotions, career development, and identify and resolve employee issues potentially impacting project performance and team spirit
' Prepare for and respond to internal/external audits

Senior DSS/MPM Responsibilities
' Perform tasks of either Senior DSS (see job description for Senior DSS) or of Medical Project Manager (see job description for MPM) as appropriate
' Work with Medical Advisors/Medical Directors/Drug Safety Physicians as needed
' Assist Regional Head of Medical Services with preparation of project resourcing estimates, leading client meetings and other management activities as needed.

Skills
' Excellent leadership and line management skills
' Excellent knowledge of drug safety and the drug development process
' Excellent knowledge of and ability to interpret and apply global safety regulations
' Experience in data analysis, evaluation of safety data and the preparation of safety reports
' Excellent team / project leadership and delegation skills
' Ability to train and mentor people
' Excellent presentation skills
' Excellent interpersonal skills
' Excellent verbal / written communication skills
' Excellent time management skills
' Client focused approach to work
' Experience with computer applications including database management and pharmacovigilance related computing systems

Education
' Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification
' Associates/diploma degree in any of the above with appropriate work experience

Language Skills
' Fluent English


Minimum Work Experience
' Considerable drug safety knowledge and experience

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