Global Pharma Tek
Edison, NJ
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Job Description :
DESCRIPTION
The Pharmacovigilance Scientist supports the medical component of pharmacovigilance activities including: surveillance activities providing scientific/clinical PV expertise with a focus on the identification, evaluation and management of safety risks for the company’s products. They collaborate closely with the safety physician and cross-functional partners to evaluate and actively manage risks in accordance with global regulatory frameworks

KEY RESPONSIBILITIES

Main responsibility is to support with Pharmacovigilance in preparation of safety reports for regulatory submission (ISS, Risk management plan, DSUR, etc .
Organize and perform independently or collaboratively as necessary, the relevant safety data analysis for Safety reporting documents.
Contribute to health authority and other safety related query responses
Support Pharmacovigilance medical directors for signal detection activities .
Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc
Ensure compliance with Company and Pharmacovigilance policies and procedures.
Review literature reports with the pharmacovigilance epidemiologist .
Support PV activities as needed .
CANDIDATE REQUIREMENTS
PharmD, MD, PhD, MPH, advance healthcare degree, or equivalent professional experience
Minimum 5 years’ pharmacovigilance or relevant experience, including NDA preparation for oncology product
Experience in Risk Management Plan preparation
Thorough understanding of the drug development process and context applicable to safety surveillance activities
Knowledge of MedDRA terminology and its application
Excellent written and oral communication skills, strong attention to detail, and high performance standards for quality
Ability to analyze, interpret, and summarize complex clinical and medical literature data
Ability to prioritize and complete work in a resourceful, self-sufficient manner while maintaining a strong mentality
Displays ability to understand established procedures and communicate those procedures to others .
Exhibits comprehension of industry practices and regulations for drug development and pharmacovigilance .
Demonstrates awareness of related medical disciplines and an understanding of general concepts and some experiential detail within those areas .
Possesses computer skills to support use of electronic systems and development of writing deliverable
             

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