Senior Specialist, PV Global Safety database

World Courier

2 - 7 years

10 - 14 Lacs

noida

Posted:1 day ago| Platform:

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Skills Required

computer science training helpdesk external audit legal database migration database administration life sciences pharmacovigilance system implementation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Configure and maintain Safety and Medical information database.
Manage user accounts, roles, and access controls.
Perform routine system checks and maintenance tasks.
Provide support during system implementation and post-go-live phases.
Act as first-level support for database-related issues via the internal helpdesk tool.
Troubleshoot and resolve technical issues in collaboration with IT and vendor teams.
Assist in the creation and execution of validation documentation (URS, FRS, IQ/OQ/PQ).
Ensure systems comply with GxP, 21 CFR Part 11, and other relevant regulations.
Develop and update training materials for end-users.
Conduct training sessions and onboarding for new users.
Support internal and client-facing projects related to PV-MI technology systems.
Collaborate with cross-functional teams to implement new features or upgrades.
Analyse complex business needs presented by clients and the internal community and recommend & implement solutions.
Should be able to face internal and external audits and/or inspections
Support database migration tasks

Qualification requirement

Bachelor s degree in Life Sciences, Computer Science, or related field.
Should have 2+ years of experience in Safety Database administration and/or handling of PV/Medical information enquiries.
Familiarity with Pharmacovigilance workflows and regulatory requirements.
Experience with validation documentation and GxP compliance.
Excellent communication and interpersonal abilities.
Preferred Skills:
Experience with Medical Information/Safety systems.
Knowledge of cloud-hosted PV systems and SaaS platforms.
Detail-oriented with strong organizational skills.
Proactive and self-motivated with a problem-solving mindset.
Ability to work independently and in a team environment.

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