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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


Context and Responsibilities

Reports (at a minimum) to


Key Activities


Product Development Committee

Internal DMCs

Product Labeling

Core Data Sheet Creation & Maintenance

Package Insert / Labeling Updates

Issues management

Crisis Management

Regulatory Enquiries



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


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: