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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

Job Summary:

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


                       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.


  • 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
Tel:  +44 (0)20 3758 8855
Website:  Visit Our Web Site

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