SPECTRUM PharmaTECH Consultants Pvt. Ltd. (SPECTRUM) is a knowledge based, fully integrated Architectural and Engineering firm providing state of art solutions to clients worldwide, satisfying the strictest regulatory requirements. Spectrum employs and offers a broad range of highly experienced and motivated professionals with hands on experience and technical expertise. Started in 1995, SPECTRUM has been offering one-stop Engineering Solutions to APIs, Finished Dosage Forms (OSD, Semi Solids, and Aseptic Products.), Analytical and Microbiological Laboratories, Pilot Plants, R&D Centers, High Potent Products, Herbal Medicines, Cosmetics etc. for the past 20 years.
Post : Drug Safety/Pharmacovigilance Specialist
RESPONSIBILITIES:
• Receives safety related information from all sources, including clinical trial cases, spontaneous reports, and literature reports (U.S. and global)
• Performs triage for incoming cases, considering assessments of seriousness, listedness, and causality
• Performs accurate data entry into the safety database
• Conducts MedDRA coding
• Prepares high quality case narratives, including identifying relevant information from source documents
• Produces accurate safety reports (i.e. CIOMS/MedWatch Forms) for submission to regulatory authorities and partners
• Tracks due dates for partner submissions
• Conducts reconciliation activities with partners
• Conducts peer review of cases in the safety database for quality control
• Produces queries as needed for clarification of clinical reports
• Conducts active follow-up, including written and verbal follow-up
• Conducts reconciliation of the safety and clinical databases for serious adverse events
• Supports the management of case processing deadlines
• Extracts data from the safety database, as needed
• Compiles safety information for aggregate safety reports and other safety related reports
• Conducts departmental specific projects as needed
Candidate Profile
• A degree in a healthcare discipline is preferred (e.g. pharmacist, nurse)
• Minimum of one year of safety experience in a pharmaceutical company
• Understands local and applicable foreign safety regulations
• Strong clinical background, with ability to interpret medical records (e.g. laboratory results, medical conditions)
• Experience with use of safety databases, preferably Argus Safety Database
• Strong written communication skills, with ability to write clearly and concisely
• Attention to detail and the ability to prioritize
• Time management skills with ability to prioritize to meet required deadlines
• Ability to collaborate with team members
Additional Information:
Industry Type : Pharma
SALARY AROUND: 95000 usd / YEAR
Qualification : Degree in Pharmacy (B.Pharm)
Location : Irvine, CA
Job ID : 200-987
Last Date : 30th October, 2018
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