Safety Officer

Parsippany, NJ

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


  • 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.


  • 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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