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Pharmacovigilance Scientist

Location : Wayne NJ US 07470
Job Type : Direct
Reference Code : 19895-AB1
Compensation : 80000.00 - 100000.00 USD/YEAR
Start Date : 07/19/2019
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Biology
Travel : No
Relocation : No
Job Industry : Biotechnology

Job Description :


  • Pharmacovigilance Scientist to collect, monitor, document and generate FDA submissions for adverse reactions to comply with the company's procedures and national and international regulations.

  • Drafting regulatory policies and SOPs.

  • Conducts national research to check the listings of reported adverse reactions.

  • Ensure collection, processing, documentation reporting, forwarding and follow-up of all adverse drug reactions (ADR) reports for all products.

  • Ensure recording and tracking of receipts, submissions, quality and accuracy of ADRs, Periodic Safety Update Report (PSUR), and Periodic Adverse Experience Report (PAER).

  • Conduct periodic data reconciliation.

  • Keep abreast of local and international Pharmacovigilance activity regulations. Train and update staff to increase understanding of pharmacovigilance requirements and implementation of best practices.

  • Generates and maintains reports of drug safety complaints.

  • Interface with national and regional regulatory authorities and health professionals.to communicate relevant safety information.

  • Serve as point of contact for Health Authority Inspections and Internal Process Audits.


Required Qualifications :


  • At least a Bachelor's Degree (Master preferred) in Biology or other scientific discipline plus at least 5 years of pharmaceutical / biotechnology industry experience.

  • At least 2 years of pharmacovigilance experience including FDA submission experience.

  • Additional experience in Clinical research is preferred.

  • Demonstrated knowledge in principles of drug development, pharmacology, clinical trial methodology and design, assessment of drug/product risks and benefits, safety assessment of drugs, and global safety regulations.

  • Ability to critically evaluate safety data from clinical trials and literature to assess clinical importance and potential strategic impact of the data

  • Experience with written and oral presentations of safety data to upper management and Health Authorities.

  • Able to analyze signal detection and trends for specific products.

  • Experience with processing adverse event reports.

  • Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements.

  • Team player with Professional Integrity and strong Leadership, Problem Solving, Decision Making, and Communication skills.



Contact: Allan Berman


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Please send all inquiries to Allan.Berman@TerkoTech.com



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