Manager, IT Operations

Manager IT Operations (Pharmacovigilance - Argus)

Location: Anywhere in India (Home-Based)

Job Type: Permanent (Full Time)

Overview:

Looking for a Manager 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 have experience in Argus console, running listings in complex conditions supporting a medical safety environment and would like to be part of a department that has growth plans for 2020 and can provide excellent training and development this might me the right opportunity for you.

Job Functions/Responsibilities

• Provide Drug Safety application support
• Generate validated standard line listings from Argus safety database for DSURs, 6-monthly line listings, business partner exchange, PSURs/PBRERs.
• Generate Ad hoc safety data listings (non-validated) for internal customers
• Troubleshooting technical issues that may arise during E2B import, E2B exchange and/or global transmission of ICSRs and aggregate safety data to regulatory authorities, business partners and applicable vendors
• Provides technical/functional leadership in the Drug Safety application support function and in planning and 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
• Maintains strong knowledge with evolving international guidance and regulations for global safety reporting, safety surveillance and risk management in both a clinical and post-marketed setting (FDA, EMA, MHRA, CFDA/SFDA, PMDA and other Asia/Pacific territories)
• Support Drug Safety & PV inspection readiness activities
• Supports PV regulatory inspection safety data requests as required

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
• 10+ 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)
• Understands safety database structures and is familiar with data retrieval tools, and coding dictionaries such as MedDRA, WHODrug
• Strong experience with global safety reporting obligations within an international business environment for both clinical and post-marketed safety data (e.g.; FDA, EMA, MHRA, China, New Zealand, Japan, Australia)
• Experience with supporting time-sensitive requests for safety data listings during internal audits as well as regulatory authority inspections
• Excellent project management skills with the ability to align internal and external resources
• Bachelor's Degree in Computer Science or related field with at least 10 years of IT or direct Drug Safety Systems support including previous leadership experience, or equivalent combination of education, training and experience

What is Next?

Following your application, one of our dedicated recruiters will contact you and if successful, we will be able to provide you with more details about this opportunity.