Assistant Safety Data Manager at Hanover

Job Description

A major pharmaceutical company is seeking an Assistant Safety Data Manager located in East Hanover, NJ.Duties:To support the Group Head by performing the paper and electronic submissions of individual and periodic safety reports to the health authorities, including the distribution of investigator notifications and the distribution and tracking of follow-up queries from central processing to individual local investigator sites.Support DS&E staff and maintain Company regulatory compliance by performing paper and electronic submissions of individual case reports and periodic safety reports to the Health Authorities.Publishing and preparing documents in various electronic formats to support successful electronic transmissions of safety reports to Health authorities, license partners, etc.Proficient in electronic Common Technical Document technology for ICR submissions forINDsubmissions.Collect, track, and distribute follow up queries from central sites to local investigator sites utilizing a tracking database.Contribute in the testing and validation of PV Systems as appropriate Contribute in creation of test scripts for IT projects within DS&E as appropriate Provide support as required for regulatory authority inspections and audits.Participate in additional activities and projects as requested by the Group HeadSkills:Experience in clinical or safety data management or closely related areas of responsibilityExperience of retrieving data from relational databases Medical terminology and MedDRA knowledge.Previous experience in handling medical dataEducation:Degree or equivalent in Life Sciences or work equivalent

Job Requirements

 
Country: USA, State: New Jersey, City: Hanover, Company: InVentiv Health.