|Reference # : ||18-37802
||Title : ||Associate Manager, Drug Safety Public Health - II //Foster City, CA|
Foster City, CA
|Position Type : ||Contract|
|Experience Level : ||
||Start Date / End Date : ||07/17/2018 / 07/12/2019
| Description |
|Job Title: Associate Manager, Drug Safety Public Health - II|
Work Location: Foster City, CA
Length of Assignment: 6 Months
Position Type: Contract Full Time
Client: A Big Pharmaceutical Company
Essential Duties and Job Functions:
Testing/validation of Argus Safety application and integrations
Review and dry run test protocols (OQ/PQ)
Perform validation test execution, test execution status reporting, deviation documentation and support resolution of deviations
Formally execute test protocols (OQ/PQ) in controlled test environment. Perform testing and validation activities per Client's Standard Operating Procedures and guidelines.
Adhere to and follow company procedures for Good Documentation practices to document test results and provide objective evidence as required by test script
Collaborate with cross-functional teams (test coordinator, Validation Lead, Business representative(s), Technical teams and QA specialists in Quality/Compliance) to ensure testing and validation activities performed are in compliance with company procedures.
Participates in the identification of risks and the development of mitigation strategies for issues observed.
Scope of Work:
Author and review validation deliverables such Validation IQ, OQ, PQ protocols and IQ/OQ/PQ Qualification Summary or Validation Summary Reports.
Under the direction of immediate manager, provides troubleshooting and application
support for specific applications and solutions.
During system implementation and change management, may support, test, and refine
application configurations to align with business process needs.
Works with business and IT partners to enhance applications to reduce operating time or
Prepares program-level and user-level documentation.
May assist with software configuration management, maintenance, introduction and
Follows pre-defined task lists with given development tool.
Organizes, prioritizes, and coordinates multiple work activities to meet project
Identifies and documents business processes.
Knowledge, Experience and Skills:
The following represent common education and experience but not mandatory requirements.
General education (high school or college) with associated and related work experience
or an individual with a medico-scientific university degree
Previous experience in drug safety or clinical research desired but not essential
Frequent use and application of technical standards, principles, theories, concepts and
Provide solutions to a variety of technical problems of moderate scope and complexity.
Works under general supervision. Follows established procedures. Work is reviewed for
soundness of technical judgment, overall adequacy and accuracy.
Contributes to the completion of milestones associated with specific projects. Failure to
achieve results or erroneous decisions or recommendations may cause delays in
program schedules and may result in the allocation of additional resources.
Liaison (Internal & External Influence):
Primarily internal company contacts.
Infrequent inter-organizational and outside customer contacts on routine matters.
Required Qualifications and Skills:
Minimum BA / BS or relevant work experience in information systems, engineering, science or business.
Highly skilled in Computerized System testing and validation in the healthcare industry.
Hands-on experience with GxP systems validation (Drug Safety/Clinical systems) with at least 5-10 years of experience in validation of Argus Safety system.
Knowledge of GxP Quality / Computer system validation and applicable regulations and guideline such as FDA 21 CFR Part 11, EU Annex 11 and ICH guidelines, GAMP 5
In-depth knowledge of Systems Development Life-Cycle (SDLC) with validation aspect of software project implementation.
Solid project organizational skills. Ability to multi-task. Must have strong analytical problem solving skills.
Team player with excellent communication including written, verbal, and listening skills.
Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision.
If you are interested in this job than please send me your most updated resume on email@example.com or you can reach me at #973-507-7579