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Post: Manager, Safety/Pharmaco
Job Description:
•Line management responsibilities including transfers, hiring, utilization, terminations, training, professional development, performance appraisals, job description preparation, time sheet approval, and employee counseling. Advises staff on administrative policies and procedures, technical problems, and prioritization.
•Assigns project work and reviews workload for all direct reports. Provides oversight and guidance on organizational goals and company objectives.
•Monitors quality of work and efficiency of team members with contracted scope of work and Safety Management Plan. Discusses below-target project goals with Associate Director/Director/VP.
•Manages projects where Safety and Pharmacovigilance are the primary services:
a.Reviews study budgets and expenses; ensures all study related contractual and budgeting issues are upheld and performed.
b.Works with Finance to ensure appropriate customer invoicing, where required.
c.Approves project time cards and invoicing.
d.Provides sponsors with scheduled project updates and reports.
•Participates in the management of the Safety and Pharmacovigilance department with the following actions:
a.Assists in the development, review, and approval of departmental Standard Operating Procedures (SOPs) or ensures compliance with sponsor SOPs.
b.Ensures the execution of the Safety Management Plan/Safety Reporting Plan.
c.Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes. Participates in process development and improvement of departmental functions.
•Works with Business Development to actively solicit new business, as needed.
•Reviews, advises, and approves drug safety portions of project proposals to ensure wording adequately reflects the scope of work for drug safety. Reviews and approves clinical safety sections of study protocols and Case Report Forms (CRFs). Approves budget projections for the project. •Maintains understanding of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process.
Candidate Profile
Bachelor Degree preferably in Business or Life Sciences or equivalent experience.
•Demonstrated leadership skills.
•Strong attention to details.
•Able to make effective decisions while managing multiple workload
Additional Information:
Qualification: Bachelors Degree
Location: India, Gurgaon
Job ID: 16005095
"Industry Type: Pharma/ Biotech/Clinical Research
End Date: 20th November, 2016
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