Senior Manager, Pharmacovigilance Operations
Parexel International Corporation
USA - Any Region - Home Based
Parexel’s Pharmacovigilance Operations team is known for its amazingly supportive and collaborative culture, and the team continues to grow!
We are currently seeking a Senior Manager, Pharmacovigilance Operations to join this outstanding team in North America!
If you’re passionate about developing others and providing your direct reports opportunities to achieve their full potential and grow their careers, we would love to connect!
As a Senior Manager, you will use draw upon your PV expertise and your leadership talent to inspire and motivate our highly experienced North American team. You will have big picture oversight to multiple client programs and assist team members in achieving client strategies which can make incredible impact on the lives of patients worldwide. All while working with an incredible team, progressing professionally, and gaining tremendous exposure to a variety of therapeutic areas and interesting compounds.
The Sr. Manager, Pharmacovigilance Operations 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, as well as providing their 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).
Additional responsibilities include: 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 Medical Business Operations and/or Senior Director, Safety 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 Senior Director of Safety Operations 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 Perform tasks of either Senior DSS or of Safety Services Project Leader as appropriate Work with Medical Advisors/Medical Directors/Drug Safety Physicians as needed Assist Senior Director, Safety Operations with preparation of project resourcing estimates, leading client meetings and other management activities as needed. QualificationsSkills:
• 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
Knowledge and Experience:
• Considerable drug safety knowledge and experience (5+ years) combined with previous Line Manager experience
• Significant experience in working in drug development and/or healthcare environment EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.