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Job Details

Senior Manager - Drug Safety & Pharmacovigilance (Contract) Role

Company: EPM Scientific
Location: North Carolina
Reference: JYSR
Closing Date: 27 Jan 17
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

                       Senior Manager - Drug Safety & Pharmacovigilance (Contract) Role    Location: North Carolina Salary:...

Requirements:

                       Senior Manager - Drug Safety & Pharmacovigilance (Contract) Role 

 
Location: North Carolina

Salary: Competitive

Industry: Biopharmaceutical

Job Type: Contract

Length: 12 months 


Responsibilities include:


  • Participates in investigator meetings to train investigators and qualified site personnel in the collection and reporting of SAEs to study sponsor
  • Serves as expert on all aspects of the end-to-end case management processes with regards to global regulations, guidelines and industry best practices.
  • Ensures compliance with global regulations and guidelines with regards to safety data collections, management and reporting related to individual case management activities.
  • Interfaces with medical monitors for medical assessments and the proper regulatory classification of SAEs; reconciles SAEs with the clinical study database during and after study completion; collects, processes and reports on all post-marketing SAEs.
  • Manages the development, implementation and on-going enhancement of safety surveillance processes and the associated SOPs and Safety and Medical Management Plans (SMMP); manages PV/DS reporting process and safety review and risk management activities.
  • Provides PV/DS expertise in-house and by consultation with outside vendors for all development programs and market products; responsible for the oversight of Clinical Research Organizations (CROs) activities for both post marketing and clinical trials.
  • Responsible for the timely completion of individual cases and meeting the SLA for data entry and case analysis activity as per SOP
  • Directs and provides key input for, the review of new or ongoing safety documents that ensure compliance with domestic and international regulatory requirement
  • Represents the PV/DS function in development project teams and provides clinical guidance for pharmacovigilance activities through internal collaboration with Regulatory Affairs, Biostatistics, Clinical Operations, Commercial and Quality Assurance (QA) and others, as necessary.


Qualifications:


  • R.N., B.S.N., RPh or PharmD
  • 10 years’ experience in health care or life sciences industry with at least 3 years of experience in pharma/biotech, or equivalent combination of experience
  • 5 years of experience in pharmacovigilance with direct end to end ICSR/Case management experience with 3 years’ staff management, or equivalent combination of experience
  • Experience in the use of Electronic Document Management System software (ARGUS, ARISg)
  • Extensive Case Processing, Case Review, and Aggregate Reporting experience
  • Strong time management and organization skills

Apply for this job: Senior Manager - Drug Safety & Pharmacovigilance (Contract) Role

Contact Information:

Address:  Head Office
Ground Floor 21 Lombard Street London
EC3V 9AH
England
Tel:  +44 (0)20 3758 8855
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