Safety Systems Specialist

0-5 years

Not Disclosed

Mumbai

12 July 10, 2024

Job Description

Job Type: Full Time Education: B.Com / B.Tech/ B.E./ M.Com/ B.Sc / MBA / M.Tech/ M.E./ M.Sc/ BBA/ BA/ Any Graduate Skills: Python, Communication Skills, Power Bi, Numpy Pandas, Sql, machine learning, Data Analysis

Company Description:

PrimeVigilance (part of Ergomed Group)

Established: 2008
Type: Specialised mid-size pharmacovigilance service provider
Global Presence: Europe, North America, Asia

Services Provided:

Medical Information
Pharmacovigilance
Regulatory Affairs
Quality Assurance

Key Highlights:

Global Leader: Known for first-class support to pharmaceutical and biotechnology partners
Therapy Areas: All-inclusive, including medical devices
Employee Focus: Emphasis on training, development, well-being, and mental health
Work-Life Balance: Acknowledged as critical for employee satisfaction and high-quality client service

Mission Statement: Join us in making a positive impact on patients' lives.

Job Description:

Position: Safety Database Specialist

Team: Safety Information System Team

Responsibilities:

Database Activities:
- Data migrations requiring strong SQL developer skills
- Providing technical expertise on pharmacovigilance systems (Argus Safety database)
- Planning and validation of database-related activities
- Support and maintain the adverse event reporting system
- Ensure compliance with regulatory requirements, policies, and standards
Subject Matter Expertise:
- Pharmacovigilance systems (Argus 8.x Oracle Cloud) and associated application integrations (e.g., OAS, Axway)
- Lead client data transfers (data imports and exports)
- Develop, validate, and implement standard and custom reports
- Query database to support inspections as required
Efficiency and Quality:
- Identify database requirements to maximize efficiency and quality
- Investigate, develop, and implement solutions
- Present solutions to management proactively
Project Management:
- Configuration/validation of the pharmacovigilance master tenant enterprise
- Lead project kick-off for client enterprise creation, validation, and configuration
- Gather functional and technical requirements
- Provide configuration solutions to support client case processing and reporting
System Upgrades and Issues:
- Lead safety database and associated systems upgrades/patches
- Project planning, testing, and implementation
- Manage and escalate system issues with pharmacovigilance software vendors
Documentation and Training:
- Author pharmacovigilance system work instructions, SOPs, and associated forms
- Maintain professional and technical knowledge through continuing education
- Develop staff knowledge through individual mentoring, classroom training, and user workshops
Compliance and Additional Tasks:
- Ensure compliance with relevant company policies and procedures
- Accept project assignments as delegated by senior staff

Qualifications:

Bachelor's degree in Information Technology or related experience
Knowledge and experience with pharmacovigilance systems in a pharmaceutical company, biotech, or CRO (on-premise or cloud-based)
Experience supporting Oracle Argus Safety system and application integrations (e.g., OAS, Axway)
Understanding of pharmacovigilance processes and ability to implement technical solutions
Proficient SQL and/or PS/SQL skills
Excellent people and project management skills
Experience with system validation and compliance with global regulations
Strong analytical/problem-solving skills and ability to multi-task
Excellent oral and written communication skills
Ability to work within a global Safety Information Systems team

Additional Information:

Why PrimeVigilance?

Core Values:

Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships

What We Offer:

Training and career development opportunities
Emphasis on personal and professional growth
Friendly, supportive working environment
Opportunity to work globally with English as the company language
Equal opportunities workplace promoting diversity, equity, and inclusion

Mission Statement: We believe our people are our greatest strength, leading to our success in improving lives. We look forward to welcoming your application.

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