Director of Drug Safety and Compliance
Sterling Life Sciences - Newark, NJ

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Partial Job Description
1) Direct DSP Americas/ROW unit in the management, reporting and evaluation of AEs/ADRs for both marketed and pre-marketed products
2) Provide direction for developing and revising local processes, procedures and SOPs pertaining to safety issues
3) Coordinate with country-specific or company-specific reporting offices in the applicable region
4) Develop, manage and report the status of the DSP unit budgeting, staffing and operations
5) Prepare or review documentation, answer safety-related questions when requested by specific local regulatory authorities in collaboration with GPSAE (Global Product Safety Analysis & Evaluation) or SO (Safety Operations) as required
6) Ensure compliance for pre-marketed and post-marketed AE/ADR reports and periodic reports
7) Manage and track Key Performance Indicators (KPIs) for DSP Americas/ROW activities and report on performance results
8) Establish and implement reporting procedures with applicable affiliates, distributors and licensees
9) Prepare the DSP Americas/ROW monthly status reports
10) Represent company group during regulatory on-site audits and inspections of DSP Americas/ROW
11) Assign responsibilities to DSP Americas/ROW personnel
12) Coordinate and approve yearly training programs for DSP unit personnel
13) Provide management of invoices/contracts (tasks, quality, timelines, costs) in collaboration with the applicable responsible department
14) Head and coordinate the company global device vigilance unit in strict cooperation with applicable company group device manufacturers
15) Participate with GPSAE to prepare and revise product CSI, providing support in risk/benefit assessment
16) Participate in strategic management and coordination of data exchange with partners
17) Provide medical support in planning and implementing CDSP programs/projects and to global medical and regulatory affairs activities
18) Provide after hours support for drug safety/professional services customer requirement
19) Provide medical and safety support to Regulatory Department
20) Coordinate with other departments to perform safety-related activities
21) Conduct DSP meetings with personnel of DSP unit on a routine basis, generally once a month
22) Hold additional DSP meetings on an ?as required? basis to optimize processes
23) Train personnel on all SOPs, guidance and policies as applicable
24) Handle all managerial issues and processes within the DSP Americas/ROW unit i.e. personnel assessments, compensation suggestions, hiring processes and contract approvals

Qualifications / Skills Required
1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Life sciences industry experience

CareerBuilder - 15 months ago - save job - block
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