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ICON plc

Senior Analyst Engineer II

Posted 8 Days Ago
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In-Office
Chennai, Tamil Nadu, IND
Senior level
In-Office
Chennai, Tamil Nadu, IND
Senior level
Provide application support for pharmacovigilance systems (Argus and related platforms): user and product setup, generate validated and ad-hoc safety listings, troubleshoot E2B/ICSR transmissions, support releases, collaborate with IT/PVSS and vendors, and respond to audit and regulatory inspection requests.
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Senior Analyst Engineer II

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.


As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.


POSITION SUMMARY:

Support Pharmacovigilance and Safety Services systems including Argus and other supporting systems in line with ICON Business Strategy and IT Governance and Control objectives.

LOCATION: Chennai ( Office or Home)

EDUCATION REQUIREMENTS:

Bachelor’s Degree in Computer Science or related field with at least 3 years of IT or direct Drug Safety Systems support, or equivalent combination of education, training and experience

JOB FUNCTIONS/RESPONSIBILITIES:

  • Provide Drug Safety application support including but not limited to; user account maintenance, product setup, study setup, and license setup, and codelist maintenance. 
  • 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 assistance 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.

EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS:

  • 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
  • Direct experience with Argus, other safety data repositories and electronic data capture (EDC) platforms
  • Experience with reporting platforms, data visualization tools, and SQL/PLSQL
  • Excellent interpersonal and communication skills, both written and oral
  • Understands safety database structures and is familiar with data retrieval tools, and coding dictionaries such as MedDRA, WHODrug
  • 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

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.


Visit our careers site to read more about the benefits ICON offers.


Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.


If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply

ICON plc Chennai, Tamil Nadu, IND Office

200 Feet Radial Rd, MCN Nagar Extension, Chennai, Tamil Nadu, India, 600097

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