Senior / Manager, Safety Operations ( Pharmacovigilance)

The excitement continues, and Parexel's Pharmacovigilance team is expanding again!

Amazing opportunity to bring your PV Management experience to Parexel, oversee an incredibly talented North American Team, and join a DREAM TEAM of PV Leaders!

The Senior / Manager, Safety Operations will line manage and supervise regional Drug Safety staff on a day-to-day basics (services for Serious Adverse Events/Adverse Reactions management, periodic safety reports, literature surveillance and coding.), guiding performance of staff 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). This individual will also work to ensure compliance with relevant regulations and Standard Operating Procedures (SOPs).

The Senior / Manager will also: Cooperate with 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 Review timesheets and utilization reports and provide input into monthly reports Assist in interviews for recruitment of new personnel and in termination of employment as necessary Organize 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, support career development, and identify and resolve employee issues potentially impacting project performance and team spirit Support audits and inspections QualificationsSkills: Strong leadership and at least 1-2 years of previous line management experience are required (Senior / Manager level determination will be made based upon previous experience in a PV Operations Management role) Managing resources and resource projections to meet client expectations and contractual obligations Experience within drug safety and the drug development process Support development of SOPs and investigation of process-related issues, as well as consulting on safety processes and regulatory compliance Knowledge of and ability to interpret and apply global safety regulations Excellent team / project leadership and delegation skills Ability to train and mentor people Confidence with presentations Verbal and written communication skills Time management skills Client focused approach to work Experience with computer applications including database management and Pharmacovigilance related computing systems ie Argus Knowledge and Experience: Considerable drug safety knowledge and experience Previous line management experience Experience in working in drug development and/or healthcare environment Confident in understanding of the regulatory environment and pharmacovigilance Previous experience and/or interest in process improvement / department initiatives is a plus! This is a home-based role and East Coast candidates are preferred; however, exceptional candidates in other areas of the US will be considered if they are flexible to work East Coast hours.

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

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.