Senior Drug Safety Specialist
Location: Jersey City New Jersey
Description: Mitsubishi Tanabe Pharma America is hiring Senior Drug Safety Specialist right now, this occupation will be placed in New Jersey. For complete informations about this occupation opportunity kindly read the description below. Job Description
POSITION OVERVIEW/SUMMARY
The Senior Drug Safety Specialist is responsible for coordinating and co-authoring periodic safety re! ports including DSURs, PSURs/PBRERs and other safety aggregate reports that are submitted to health authorities.
This individual will also be responsible for completing all aspects of individual case safety report (ICSR) processing and reporting for assigned investigational and marketed products, as well as contributing to study documents, ad hoc risk assessment reports, and assisting management in establishing and implementing departmental strategy.
The Senior Drug Safety Specialist supports and participates in drug safety assessment, evaluation and management. The Senior Drug Safety Specialist serves as a liaison to external service providers (i.e. clinical research organizations), investigational sites, and company personnel for safety-related issues, working in close collaboration with colleagues from Clinical Research, Data Science, Regulatory and Quality Assurance.
KEY RESPONSIBILITIES
Contributes to, authors and reviews safety sect! ions of clinical trial protocols, investigator brochures, and ! informed consents for his/her assigned drug development programs. Contributes to, authors and reviews developmental risk management plans. Coordinates the preparation and authors DSURs, PSURs/PBRERs and other safety aggregate reports when required, in accordance with the needs of the Health Authorities or required to work up a potential signal or risk, collaborating with management, safety physicians, medical monitors, epidemiologists and other internal and external colleagues as appropriate. Ensure that all ICSRs received from any source (clinical trials and post-marketing) for assigned products and/or studies, are processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs, policies and procedures. Ensure that all domestic and foreign ICSRs received by Company are appropriately triaged and scheduled in Company safety database based on the following criteria: source, seriousness, data entry priority, initial vs. follow-up report. Ensure! consistency in the initial evaluation and assessment of incoming ICSRs and source documentation for completeness, accuracy & legibility. Ensure appropriateness of MedDRA and WHO-DD coding performed by Drug Safety staff. Liaise with assigned Physicians in Drug Safety to ensure that appropriate medical review and assessment is provided for assigned case reports. Perform follow-up (telephone, e-mail or facsimile), as needed, either directly with reporter or through appropriate CRAs, and document results in case file. Communicate with partner companies, collaborative sponsors and their respective clinical research organizations (CROs) regarding the evaluation and processing of ICSRs. Maintain working knowledge of relevant regulations, ICH/industry guidelines, company policies and assigned products as related to drug safety evaluations Perform other departmental duties as assigned. May require some domestic and/or international travel
Qualifications
Educati! on:
Minimum BA/BS in Science, Epidemiology, Pharmacy, Nursingor! equivalent Advanced degree in relevant disciplines such as Epidemiology, Medicine, Nursing, BiologicalSciences and/or Drug Development desirable Professional Experience:
2+ years of pharmaceutical industry experience in Drug Safety, Device Safety, Medical Affairs, Regulatory,Clinical Development or related field
Knowledge andSkills:
Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization. Outstanding communication skills (verbal and written) Strong analytical and problem solving skills Good clinical judgment and ability to communicatecomplex clinical issues in a scientifically sound and understandable way Knowledge of regulations as they apply to drug safetysurveillance for both IND and NDA reporting. Working knowledge of Drug Safety databases Attentiveness todetails, strong organizational skills, proactive and independent approach, excellent verbal communication, and team spirit. Experience mana! gingprojects in all phases of clinical and post-marketing safety surveillance. Possess solid understanding of regulations as they apply to drug surveillance for both IND and NDA reporting. Working knowledge of Food and Drug Administration Regulations, including but not limited to: 21 CFR, 312 and 314, GCP, ICH, CIOMS and EU GVP modules. Knowledge of individual case safety report processing, aggregate analysis and reporting,and an understanding of North American, EU, Japan & ICH pre-andpost-marketing pharmacovigilance regulations. Proficiency inExcel, Word, & Powerpoint programs
Additional Information
We offer an excellent compensation and benefits package and a congenial, entrepreneurial work environment. Our office is in the Newport Tower in Jersey City and is convenient to public transportation.
MTDA is an equal opportunity employer.
- .
If you were eligible to this occupation, please email us your resume, with salary requirements a! nd a resume to Mitsubishi Tanabe Pharma America.
If you interested on this occupation just click on the Apply button, you will be redirected to the official website
This occupation starts available on: Mon, 19 Aug 2013 17:23:20 GMT