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Drug Safety Specialist

Company: Systems Technology International
Location: Jersey City
Posted on: September 16, 2020

Job Description:

Systems Technology International, Inc. (STI), a full service innovative professional services corporation serving in virtually every industry. STI offers professional services in the Technical/Engineering, IT (Information Technology), Creative and marketing, Business Analyst, Accounting and office support areas.. Job Description. Drug Safety SpecialistCompany Work Location: Jersey City, NJDomain: Health Care. Candidates must have Green card or US Citizens ONLY. Job Description:. Experienced Drug Safety Specialist is required having Responsible for Safety Alliance Management (SAM) Associate guides and facilitates effective working relationships with Actavis Patient Safety, Actavis’ associated business partners (ABPs), as well as strategic departments within the company’s affiliates/subsidiaries to foster contract agreements and ensure the smooth, accurate, and timely flow of functions related to onboarding.. Responsibility:. • Responsible for ABP alliance activities. Serve as the liaison between Actavis Patient Safety and ABP drug safety organizations. Support ABP onboarding for new partnerships and maintenance. • Manage the onboarding process, establishing SDEAs/PVAs with ABPs for new products. • Interact with ABP for additional information to address questions in establishing SDEA/PVA, as well as request safety information to support pharmacovigilance efforts. • Coordinate the SDEA/PVA review by the safety review team, summarize agreement comments, and participate in the negotiation of the agreement. • Collaborate with the cross-functional groups that have responsibility of ABP activities within Actavis, such as (not limited to) Business Alliance, Clinical Development, Regulatory Affairs, Clinical Operations, Quality Assurance, Legal, and Project Management. • Maintain and organize internal SAM files (ABP agreements, supporting documents, meeting minutes). • Initiate/Develop/Review/Update departmental procedural documents such as SOPs and Training Guidances. Collaborate effectively with authors, reviewers, approvers and trainers. • Support audit and inspection activities, as needed. • Assist with project management activities.. Required Skills:. Education: • Healthcare professional with a BA/BS degree in Pharmacy or Nursing • MA/MS or PharmD degree in Pharmacy or Nursing is preferred. Experience:. • 3-5 years experience in pharmaceutical industry, with at least 2 years in Drug Safety • Experience with global drug safety regulations (i.e., FDA, EMA, MHRA, Bfarm, etc.) andworking in a global pharmaceutical drug safety department • Experience working with partners and distributors • Knowledge of GVP, ICSR Reporting, Periodic Safety Reports (PADER, DSUR,PSUR/PBRER) • Project management experience • Experience with process improvement initiatives • Audit/inspection experience preferred • Experience working with and interacting with diverse groups is preferred • Advanced knowledge of medical terminology, clinical terms, MedDRA, U. S. Code of• Federal Regulations and global regulations regarding AE reporting • Advanced knowledge of drug safety processes, standards, conventions, and governance Drug safety case processing and reporting knowledge. (FOR FASTER PROCESS: Just go to Google and Search "STI JOBS" you will see the website in the top listing. Go through the website and search the Job in the search box. Apply Directly through the website. ). Additional Information. (FOR FASTER PROCESS: Just go to Google and Search "STI JOBS" you will see the website in the top listing. Go through the website and search the Job in the search box. Apply Directly through the website)

Keywords: Systems Technology International, Jersey City , Drug Safety Specialist, Other , Jersey City, New Jersey

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