Summary of the Position:
The Safety Database Administrator is responsible for maintaining the pharmacovigilance platform enabling the organization to make faster and better safety decisions, optimize global compliance, and easily integrate risk management. The Safety Database Administrator will be responsible for the management, configuration, and assisting with the validation of all safety systems, including without limitation Argus Safety and Nukleus Safetybase, contributing to activities including case management, database configuration, study start-up, and safety reporting.
Essential Functions:
Support the day-to-day running of applications to sustain Drug Safety objectives, including without limitation Argus Safety, Nukleus Safetybase, MedDRA, WHO Drug Dictionary, and business intelligence tools.
Assist with the configuration of safety database for products, studies, user privileges and workflow.
Perform programming, validation, and front-end advance conditions (e.g., query sets, generation of custom reports for data analysis, routine and ad hoc data extractions) to meet internal business requirements based on contracted timelines.
Ensure all safety database activities are completed in accordance with SOPs and other applicable regulations and understand how regulatory changes (EMA/FDA) may impact the department.
Take part in impact analysis of changes to Drug Safety Systems identifying the risks and benefits associated with the change. Keep management aware of potential and actual issues and integrate risk management.
Review documentation associated with pharmacovigilance SOPs as related to the safety database.
Act as liaison with IT and vendors to support release and/or patches delivery.
Train, assist and support the Pharmacovigilance Team and other end-users as a System and Database Administrator for technical support.
Assist in developing solutions for ongoing improved pharmacovigilance.
Evaluate proposed project ideas/software changes through technical impact analysis and estimated business value to contribute to decision-making.
Manage safety system access requests (internal and external).
Maintain up-to-date knowledge of regulatory requirements for safety reporting as it relates to the safety database.
Manage safety database upgrades and change control processes.
Provide guidance on additional projects as needed.
Perform other tasks as may be required and agreed to from time to time.
Knowledge, Skills and Abilities:
Expert knowledge of Oracle Argus Safety
Computer competence (Microsoft Office essential; clinical trial packages are added advantages)
Strong planning, organizing and administration skills.
High degree of accuracy and problem-solving capabilities.
Able to identify errors and take corrective action within area of responsibility without compromising quality.
Self-motivated, positive attitude with good communication and interpersonal skills.
Ability to handle multiple tasks simultaneously and effectively.
Ability to work independently and as part of a growing team.
Ability to foresee potential pitfalls in projects and to implement strategies to mitigate potential risks.
Work on significant and unique issues where analysis of situations or data requires evaluation of variables that may impact future concepts, products, and technologies.
Possess good organizational and communication skills.
Knowledge of Windows server operating systems and environments
System Validation knowledge โ IQ/OQ/PQ
Proficiency in related, underlying technologies, including SQL, Oracle, XML, and integration technologies and standards.
Previous experience writing simple automation scripts using any language (VBScript, PowerShell, etc.) preferred.
Understanding of local and wide area networks, protocol, and simple network troubleshooting.
Solid technical background and experience working with Oracle Safety Argus Suite.
Possess fine-tuned analytical and troubleshooting skills and/or programming experience.
Should have worked on any ticketing tool.
Position Requirements:
Education: Bachelorโs or higher graduate degree (or its international equivalent) in a medically related, or scientific field. In lieu of a degree, an equivalent combination of diplomas, certification or relevant work experience is required. Licensed or certified healthcare training will be beneficial.
Preferred Job-related Experience: A minimum of 3 years of demonstrated experience in Pharmacovigilance or CRO experience is preferred. A minimum of 3 years of Argus safety administration experience is preferred.
Additional Eligibility Qualifications:
Proficient in using Microsoft applications (Outlook, Word, Excel, PowerPoint, OneDrive & Teams).
Expert knowledge and experience in Argus safety database in front and back-end use including trial-specific configuration.
Good knowledge of ICH GCP, and relevant FDA, EMA and other international guidelines.
Expert knowledge of safety monitoring principles and practices. Knowledge of Dictionary Upgrade MedDRA / WHO Drug Dictionary preferred.
Proficiency in related, underlying technologies, including SQL, Oracle, XML, and integration technologies and standards.
Knowledge of the clinical drug development industry, procedures/processes, and regulatory standards is desirable
Preferences:
Familiarity with FDA and EMA Drug and Device Safety Reporting regulations is desirable
Physical Expectations:
Typical office environment.
Ability to sit and stand for extended periods of time.
Ability to lift or move 5-15 lbs. or 2.26 โ 6.8kg.
Travel Requirements:
Expected travel time is less than 10% for this position.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.
FHI Clinical, Inc. and its subsidiary and affiliate companies provide equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.
This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.
Our values and commitments to safeguarding: FHI 360 is committed to preventing any type of abuse, exploitation and harassment in our work environments and programs, including sexual abuse, exploitation and harassment. FHI 360 takes steps to safeguard the welfare of everyone who engages with our organization and programs and requires that all personnel, including staff members and volunteers, share this commitment and sign our code of conduct. All offers of employment will be subject to appropriate screening checks, including reference, criminal record and terrorism finance checks. FHI 360 also participates in the Inter-Agency Misconduct Disclosure Scheme (MDS), facilitated by the Steering Committee for Humanitarian Response. In line with the MDS, we will request information from job applicantsโ previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicantโs tenure with previous employers. By applying, job applicants confirm their understanding of these recruitment procedures and consent to these screening checks.
FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.
FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others โ and yourself.
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