Job Summary
We are hiring a Manager – Global Safety Database for our Research & Development team in Mumbai, India. The role involves maintaining and supporting the Global Pharmacovigilance (GPV) safety database and associated IT applications. The ideal candidate will possess strong technical expertise in ARISg, SQL, Oracle, and Java, along with a solid understanding of pharmacovigilance processes, regulatory requirements, and system validation. This position offers an exciting opportunity to bridge technology with global drug safety operations.
Key Responsibilities
Maintain and support validated PV Global Safety Database and related IT systems.
Provide application support for all validated IT tools used by GPV.
Consult users to identify optimal solutions for business and safety data requirements.
Manage and execute database optimization and upgrade projects.
Act as an interface between GPV, Abbott IT, and external software vendors.
Communicate with service providers and software vendors to ensure seamless operations.
Functionally lead external teams, ensuring adherence to defined processes and regulatory guidelines.
Required Skills & Qualifications
Degree in IT, Documentation Sciences, or a related field.
Minimum 5 years of experience maintaining safety databases (preferably ARISg) in the pharmaceutical industry.
Solid understanding of pharmacovigilance (PV) processes and global regulatory standards.
Strong IT skills including proficiency in SQL, Oracle, Java, and XML.
Demonstrated validation experience in pharma IT applications.
Excellent verbal and written communication skills in English.
Familiarity with ISOtrain-based training systems preferred.
Perks & Benefits
Competitive salary package (Not specified in JD).
Opportunity to manage global safety systems in a leading pharmaceutical environment.
Cross-functional exposure to pharmacovigilance, IT, and regulatory teams.
Professional development through system optimization and upgrade projects.
Company Description
A global healthcare and pharmaceutical leader dedicated to ensuring the safety and efficacy of medical products. The organization emphasizes innovation, compliance, and operational excellence in its pharmacovigilance and IT systems management.
Work Mode
On-site – Mumbai, India
Call-to-Action
If you are an IT specialist passionate about global safety database management in the pharmaceutical industry, apply now to join our dynamic team in Mumbai!
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