Senior Analyst Engineer

Senior Analyst Engineer (Pharmacovigilance)

Location: Anywhere in India (Home-Based)

Job Type: Permanent (Full Time)

Overview:

Looking for a Senior Analyst Engineer to support Pharmacovigilance and Safety Services systems including Argus and other supporting systems in line with ICON Business Strategy and IT Governance and Control objectives. If you are an SME in Argus safety database this might me the right opportunity for you.

Job Functions/Responsibilities

* Provide Drug Safety application support

* Generate standard line listings from Argus safety database for DSURs, 6-monthly line listings, business partner exchange, PSURs/PBRERs.

* Generate Ad hoc safety data listings for internal customers

* User access management in Safety systems like Argus Safety. Periodic review of user access.

* Dictionary management (MedDRA , WHODrug) for multiple tenants in a multi-tenant Argus setup

* Provides technical/functional expertise in the Drug Safety application support function and in deployment of new releases

* Collaborates closely with IT and PVSS department in setting a high standard with respect to protection of safety data systems and access.

* Triages and leads root cause analyses (RCA) for complex business issues with respect to safety systems issues and data integrity

Experience/Skills/Knowledge Requirement:

• Ability to establish and maintain effective working relationships with coworkers, managers, interdepartmental stakeholders and applicable vendors (CROs)
• Able to adjust to multiple demands and shifting priorities and react constructively in a high-energy, fast paced environment
• 5-8 years of direct experience with Argus Safety and electronic data capture (EDC) platforms
• Experience with OBIEE reporting platform, other data visualization tools, and SQL/PLSQL
• Excellent interpersonal and communication skills, both written and oral
• Expert in the structured E2B fields of Argus Safety database and facility with knowing how to successfully ensure E2B imports, exports and global transmissions are successfully managed and acknowledged by external parties (e.g.; regulatory authorities, vendors, business partners)
• Bachelor's Degree in Computer Science or related field with direct Drug Safety Systems support including previous leadership experience, or equivalent combination of education, training and experience.