Senior Analyst Engineer II

Posted 10 Days Ago
Be an Early Applicant
Chennai, Tamil Nadu, IND
In-Office
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
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.
Summary Generated by Built In
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

Skills Required

  • Bachelor's degree in Computer Science or related field with at least 3 years of IT or direct Drug Safety Systems support
  • Direct experience with Argus (Argus safety database)
  • Experience with other safety data repositories and electronic data capture (EDC) platforms
  • Experience with reporting platforms, data visualization tools, and SQL/PLSQL
  • Understanding of safety database structures, data retrieval tools, and coding dictionaries such as MedDRA and WHODrug
  • Experience troubleshooting E2B import/exchange and global transmission of ICSRs
  • Experience supporting time-sensitive safety data requests during audits and regulatory inspections
  • Excellent interpersonal and written/oral communication skills
  • Ability to manage shifting priorities and work in a fast-paced environment
  • Strong project management skills and ability to align internal and external resources

ICON plc Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICON plc and has not been reviewed or approved by ICON plc.

  • Healthcare Strength Benefits are described as comprehensive, with medical coverage and wellness initiatives highlighted. Larger sites are also associated with added wellness supports such as onsite fitness options and access to an employee assistance program.
  • Leave & Time Off Breadth Time-off and flexibility provisions are positioned as a meaningful part of the total package, including vacation/annual leave and flexible work scheduling. Flexibility is sometimes cited as helping offset long hours in certain roles.
  • Retirement Support Retirement and savings support is presented as a core component of the benefits package, including offerings such as pension arrangements in some locations and a U.S. 401(k) plan with company match. Financial planning resources are also emphasized as part of broader security benefits.

ICON plc Insights

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The Company
HQ: Dublin
34,685 Employees
Year Founded: 1990

What We Do

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

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