Safety Officer

Parsippany, NJ

Post Date: 07/07/2017 Job ID: 7612 Industry: Industry Pay Rate: $100,000 - $120,000/yr.

RESPONSIBILITIES

  • Manages the local pharmacovigilance, medical device vigilance, and cosmetovigilance activities of the company.



  • Reviews all incoming complaints and information requests and ensures compliant collection, data entry, routing, and follow-up of individual case reports.



  • Creates case narratives and codes adverse events in MedDRA.



  • Performs quality control activities to ensure complete and accurate case processing.



  • Reviews cases for listedness and submits reportable cases to FDA.



  • Prepares periodic safety reports.



  • Provides safety training for employees and contractors.



  • Develops and updates vigilance SOPs and forms.



  • Monitors regulatory development in vigilances activities for marketed products.



  • Ensures Good Vigilance Practices and be able to identify, implement and monitor corrective and preventive actions if necessary.





QUALIFCATIONS

  • Degree in medicine, pharmacy or life sciences



  • 5+ years of relevant pharmacovigilance experience. Cosmetovigilance or medical device reporting is a plus.



  • Safety experience includes actual experience processing safety reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.



  • Familiarity of regulatory requirements and reporting rules for adverse drug experiences.



  • Rigour, analysis and synthesis capabilities.



  • Knowledge of medical and drug terminologies is required.



  • Reactivity and ability to alert, in a timely manner, CVD/CCD and other functions on vigilance issues/alerts which occur at the national level.



  • Knowledge of MS Word, Excel, PowerPoint and Outlook.



  • Must be detail oriented and have strong organizational, problem solving and analytical skills.



  • Strong communication skills, both verbal and written.



  • Ability to develop and articulate ideas.



  • Ability to juggle multiple priorities and a team player.



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