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
To search all of our 100+ jobs, please visit https://jobs.terkotech.com/
Please send all inquiries to Allan.Berman@TerkoTech.com