Director of Drug Safety & Pharmacovigilance
Company: EPM Scientific
Location: New Jersey
Closing Date: 15 Dec 16
Salary (£): Negotiable
Director of Drug Safety & Pharmacovigilance (Contract) Role at Leading Biotechnology Company Location: United States, New Jersey Salary: Competitive Industry: Biopharmaceutical Job Type: Contract...
Director of Drug Safety & Pharmacovigilance (Contract) Role at Leading Biotechnology Company
Location: United States, New Jersey
Job Type: Contract
Length: 12 months
- Participates in investigator meetings to train investigators and qualified site personnel in the collection and reporting of SAEs to study sponsor
- 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.
- MD graduate
- 8+ years of pharmaceutical experience in a Drug Safety/Pharmacovigilance unit
- 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