Safety Systems Specialist

3 tygodni temu

Katowice, Silesia, Polska Pharmiweb Pełny etat
Job Summary

Pharmiweb is seeking a highly skilled Safety Systems Specialist to join our team. As a key member of our Pharmacovigilance Operations team, you will be responsible for configuring, administering, and maintaining the Argus Safety database on a per project basis to ensure sponsor specific requirements are met.

Key Responsibilities

Develop and maintain a repository of all relevant documents, including training materials, safety and pharmacovigilance project finance, proposals tracking, and departmental metrics.

Develop and maintain Job Aids and process documents, and maintain supporting documentation for these documents as needed.

Maintain knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and pharmacovigilance reporting.

Facilitate SPVG Annual Revenue targets by working with the operational SPVG team members and Therapeutic BU PMs/Project Directors to ensure accurate and timely recognition of the BU in RBB.

Provide SPVG metrics as appropriate at agreed-upon intervals based on assigned tasks.

Perform other work-related duties as assigned.

Requirements

Bachelor's degree in life science, registered nurse, pharmacist, computer science, or technology-related field (technical role) or equivalent combination of education and experience.

Safety Database systems and moderate medical terminology required.

Extensive clinical research work, data collection/computer systems, or equivalent experience, including understanding and application of principles, concepts, practices, and standards in the pharmaceutical or CRO industry preferred (technical role).

Excellent computer skills and knowledge of relational databases, Oracle Insight/Analytics/Data Mart, and Crystal Reports/Business Objects, SQL Plus experience preferred (technical role).

Excellent knowledge of ICH guidelines and regulations relating to safety and pharmacovigilance.

Proficiency in Microsoft Office Suite (Word, Excel, Visio, and PowerPoint), email (Outlook), and internet.

Ability to work independently and in a team environment.

Ability to successfully prioritize and work on multiple tasks and projects.

Excellent communication, presentation, interpersonal skills, both written and spoken.

Strong organizational and documentation skills.

Detail-oriented with a high degree of accuracy and ability to meet deadlines.

Able to make effective decisions.

Manage multiple priorities.

Minimal travel may be required.

About Pharmiweb

Pharmiweb is a leading provider of clinical research services, with a strong commitment to excellence and customer satisfaction. We are passionate about developing our people, through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program. We are committed to our Total Self culture, where you can authentically be yourself, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for, and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we're able to create a place where everyone feels like they belong.

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