Safety Data Management Specialist
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Job Location:
Parsippany, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
Position Details:
Our client a world-leading Pharmaceutical Company in Parsippany NJ is currently looking for a Drug Safety Associate to join their expanding team.
Job Title: Drug Safety Associate
Duration: 12 months contract extendable up to 36 months
Location: Parsippany NJ
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Our client a world-leading Pharmaceutical Company in Parsippany NJ is currently looking for a Drug Safety Associate to join their expanding team.
Job Title: Drug Safety Associate
Duration: 12 months contract extendable up to 36 months
Location: Parsippany NJ
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Safety Data Management Specialist
Reports to Country Safety Lead or Safety Team Lead or Safety Officer
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.
Reports to Country Safety Lead or Safety Team Lead or Safety Officer
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.
Primary Responsibilities
Carry out case processing activities.
Review rank verify process and document case-related information: event 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 cases 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 Pfizer policies
Participate as appropriate in local internal and external safety activities
Carry out case processing activities.
Review rank verify process and document case-related information: event 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 cases 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 Pfizer policies
Participate as appropriate in local internal and external safety activities
Technical Skill Requirements
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
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
Qualifications (i.e. preferred education experience attributes)
Health Care Professional or equivalent experience preferred.
Bachelors degree in science discipline
Ability with supervision 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 standards of performance.
Ability to work under supervision in a matrix organization.
Fluency in spoken and written English
Health Care Professional or equivalent experience preferred.
Bachelors degree in science discipline
Ability with supervision 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 standards of performance.
Ability to work under supervision in a matrix organization.
Fluency in spoken and written English
Key Skills
- Microsoft Office
- Computer Skills
- Construction Experience
- Food Safety Experience
- Root cause Analysis
- Microsoft Powerpoint
- OSHA
- Child Protective Services
- EPA
- Unity
- EHS
- Manufacturing
