Manager, Safety Operations

The Manager/Team Manager/Sr. Team 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 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 projectsEnsure 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 reportsAssist in interviews for recruitment of new personnel and in termination of employment as necessaryOrganize mentoring and training (general and on-the-job) for new staff and ensure continuous training within the department and with other departments, where appropriatePerform annual appraisals, support career development, and identify and resolve employee issues potentially impacting project performance and team spiritSupport audits and inspectionsQualificationsSkills:

Strong leadership and line management experienceManaging resources and resource projections to meet client expectations and contractual obligationsExperience within drug safety and the drug development processSupport development of SOPs and investigation of process-related issues, as well as consulting on safety processes and regulatory complianceKnowledge of and ability to interpret and apply global safety regulationsExcellent team / project leadership and delegation skillsAbility to train and mentor peopleConfidence with presentationsVerbal and written communication skillsTime management skillsClient focused approach to workExperience with computer applications including database management and Pharmacovigilance related computing systems

Knowledge and Experience:

Considerable drug safety knowledge and experienceExperience in working in drug development and/or healthcare environmentConfident in understanding of the regulatory environment and pharmacovigilanceEEO 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.