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Manager, Safety Trials and Surveillance, Senior Drug Safety Associate

Company: N/A

Location: Nationwide, NJ, USA, CA

Pay: N/A

Contact Information


Name: Lou Pasquarello
Phone: 877.267.1259
Fax: n/a
Apply Online

Job Description

TechData is looking for Biostatistician/SAS Programmer/Statistical Programmer (Some can be telecommuting), Health Economics & Outcomes Research (HEOR Biostatistician), Manager of Sales Analytics Positions, Global Medical Information Specialist/Therapeutic manager (Pharm. D), Drug Safety Specialist/Trial Safety Manager, Sr. Clinical Data Manager for our pharmaceutical clients in Northern NJ. Please see below requirements and send your resume to: [Click Here to Email Your Resumé]. TechData is a leading provider for temporary and permanent positions in the pharmaceutical industry. TechData offers the most competitive pay rates and benefits in clinical research consulting services.



Manager, Trials Safety Surveillance


Purpose




Context and Responsibilities



Reports (at a minimum) to



Responsibilities




Key Activities


Governance


Product Development Committee



Internal DMCs




Product Labeling


Core Data Sheet Creation & Maintenance



Package Insert / Labeling Updates




Issues management




Crisis Management




Regulatory Enquiries




AE CASE MANAGEMENT


Triage



Conventions Maintenance




Commercialization support and liaison to other functions


Commercial Support



CRO Selection




CRO Contracts




Trial Safety Support


Product Specific Support


EOP2 Package & Pre NDA meeting support



Informed Consent (Core content)




EU CTD Annual Report




IND Annual Report




Product Safety Surveillance Plan



Risk Management Plan development




Investigator Brochure



 


IRB Updates / Responses




Investigator enquiries




Individual Study Planning


Clinical Protocol and Safety Endpoints Definition




Statistical Analysis Plan




Clinical Data Management Plan




Case Report Form Development




Safety Management Plan Development (Logistics, data flow focused)




Coding Conventions Creation and Review



Protocol updates




Informed Consent Updates




SAE Reconciliation




Clinical Line Listing Analysis and Reporting




Periodic Safety Database Locking




Developmental Product Safety Monitoring & Surveillance (Protocol specific)




Protocol specific analysis of aggregate CTDB (frequency tables, shift tables, listings)


Developmental Product Safety Monitoring & Surveillance (Product wide)




Study Safety Data Review and Interpretation


Clinical Study Report




Integrated Summary of Safety




120 Day Update



Compliance, Standards, Training & Project Management




Job Requirements

Sr. Drug Safety Associate


Summary


The Senior Drug Safety Associate encompasses a key role in the day-to-day functioning of the Pharmacovigilance and Drug Safety department.  Responsible for overseeing all aspects of adverse event processing and reporting for assigned investigational and marketed products, while also assisting management in establishing and implementing departmental strategy.  Serves as a liaison to external healthcare providers, investigational sites, and company personnel for safety-related issues; working in close collaboration with colleagues from Clinical Science, Clinical Operations, Biometrics, Regulatory & QA, MedSA and Commercial.


Essential/Primary Duties, Functions and Responsibilities:


(In order of importance, list primary responsibilities, functions or duties which occupy more than 5% of the incumbent’s time.)



Adverse Event Case Management Responsibilities:



Additional Safety Management Responsibilities:



Departmental and Line Management Responsibilities:



Work Experience: