Associate Director, Drug Safety
Worldwide Clinical Trials - King of Prussia, PA

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SUMMARY: Under the direction of the Vice President, Global Drug Safety, The Manager, Drug Safety is considered part of the Drug Safety department’s leadership team and leads the Americas safety hub\ manages the activies and staff of the US Drug safety hub, assuring harmonziation with the other safety hubs under the direction of the VP DS

RESPONSIBILITIES:
Tasks may include but are not limited to:
Management and Development of US Hub Staff, including DSAs, Sr. DSAs, , located therein.

Act as an operational guidance resource for all ongoing (and potential) studies

When assigned, liaise with sponsors on global/general safety issues

Ensure applicable documentation and processing of serious adverse event and Serious Adverse Drug Reactions occurs as per agreed contractually and that all processing activities are conducted in accordance with all US regulations

Participate in the development of procedures (SOPs, WP,s, etc) to structure the above activities

Review US DS hub department status reports, keep DS management apprised of any potential/actual study or staffing issues, and assist with developing solutions

Ensure appropriate resolution of US DS Hub departmental personnel issues

Assist with assignment staff to newly awarded projects

Assits in the interdepartmental liaison between Safety staff and other WCT departments as well asexternal vendors for project related issues

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

REQUIREMENTS:
Safety background (nursing, pharmacy, or medicine) with relevant clinical experience

8 years drug safety or Pharmacovigilance experience

Excellent computer skills (Word, Excel, Access)

Excellent organizational and time management skills

Excellent communication skills

Excellent presentation skills

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

Required Skills

Required Experience

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About Worldwide Clinical Trials Worldwide Clinical Trials is a global CRO providing full-service drug development services to the...