NewarkRecruiter Since 2001
the smart solution for Newark jobs

Safety Data Management Specialist

Company: Unicon Pharma
Location: Newark
Posted on: May 21, 2020

Job Description:

Job Description: Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of clients products and to meet regulatory requirements. Determination of local submission of individual and, where appropriate, aggregate safety reports Carry out case processing activities Review, rank, verify, process and document case-related information: terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments Review case criteria to determine appropriate workflow for case processing Assess case to distinguish those with particular complexities and/or specific issues, and escalate appropriately Write and edit case narrative Determine and perform appropriate case follow-up, including generation of follow-up requests Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios Liaise with key partners, locally, and other stakeholders regarding safety data collection and data reconciliation Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database Determine reportability of scheduled reports, ensuring adherence to regulatory requirements Consistently apply regulatory requirements and policies Participate, as appropriate, in local, internal and external safety activities Reports to Country Safety Lead or Safety Team Lead or Safety Officer (depending on local organization and safety group size) Skills: Experience in pharmacovigilance and/or data management preferred but not required Experience and skill with medical writing an advantage Demonstrated computer literacy Experience in use and management of relational databases preferred Additional Requirements: Health care Professional or equivalent experience preferred Ability, with supervison, to solve routine problems and to surface issues constructively Ability to make basic decisions with an understanding of the consequences Ability to achieve personal objectives while meeting departmental standard of performance Ability to work under supervison in a matrix organization Fluency in spoken and written English

Keywords: Unicon Pharma, Newark , Safety Data Management Specialist, Executive , Newark, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Senior Data Product Manager
Description: DescriptionThe Senior Data Product Manager will help create and deliver best-in-class data products and drive the creation and execution of product roadmaps for innovative solutions based on data capabilities (more...)
Company: Healthfirst
Location: New York
Posted on: 05/29/2020

A2P SMS Sales Account Manager as REMOTE Position - Full Time
Description: Position A2P SMS Sales Account Manager Location REMOTE Format Full Time Description Looking for a successful and dynamic senior Sales manager who will cover big OTTs, CPaaS, MNOs, RSPs AggregatorCarriers (more...)
Company: E Solutions, Inc.
Location: Matawan
Posted on: 05/29/2020

Global Information Security Risk & Governance Manager
Description: Help us improve access to life-changing therapies that can transform human health We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture (more...)
Company: Danaher
Location: New York
Posted on: 05/29/2020

Government Underwriting Manager -REMOTE
Description: Government Underwriting Manager -REMOTE br Job title: Government Underwriting ManagerLocation: San Francisco, CAWe are a rapidly growing team and we are looking for an experienced and motivated Government (more...)
Company: CyberCoders
Location: New York
Posted on: 05/29/2020

Assistant Nurse Manager, General Pediatrics
Description: NYU Langone Health is a world-class, patient-centered, integrated academic medical center, known for its excellence in clinical care, research, and education. It comprises more than 200 locations throughout (more...)
Company: NYU Langone Health
Location: New York
Posted on: 05/29/2020

Executive Director, Leveraged and Structured Solutions (LSS)
Description: About Standard Chartered We are a leading international bank focused on helping people and companies prosper across Asia, Africa and the Middle East. To us, good performance is about much more than turning (more...)
Company: Standard Chartered Bank
Location: New York
Posted on: 05/29/2020

Principal, Relationship Management
Description: BNY Mellon Securities Corporation seeks a Principal, Relationship Management in NewYork, NY, to independently develop the strategic plan for managing and growingexisting client relationships, with a focus (more...)
Company: Bny Mellon Investment Management
Location: New York
Posted on: 05/29/2020

Admissions Director
Description: We're looking for a candidate to fill this position in an exciting company. ul li Maintains awareness of admitting
Company: HCR ManorCare
Location: Mountainside
Posted on: 05/29/2020

Senior Software Engineer - Trade Order Management System (Contract)
Description: Thousands of traders and salespeople across the globe rely on the renowned Bloomberg TOMS Trade Order Management System to run their business. TOMS delivers global, multi-asset, solutions for trade (more...)
Company: Bloomberg
Location: New York
Posted on: 05/29/2020

Clinical Site Manager (CRA) - New York (Home-based)
Description: Parexel has launched a new clinical operating model to drive effectiveness, reduce hand-offs and increase employee, client and site satisfaction. Within this model, the Clinical Site Manager CSM , formerly (more...)
Company: PAREXEL
Location: Port Reading
Posted on: 05/29/2020

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

Newark RSS job feeds