Sr Spclst Technical Product Management

Job Description

Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We partner internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.

The Information Technology team at our Companys R&D division is looking for Senior Product Analyst to support the Patient Safety and Quality & Compliance Product Line. The individual will be responsible to deliver high quality IT solutions/services for our PV Signaling Reporting and Analytics Product leveraging broad IT knowledge to transform business needs into IT requirements and deliver them with the larger IT team and vendors. Understanding of GxP compliance business strategy goals challenges/pain points IT architecture data platform standard applications and external environment changes is expected.

Primary Activities / Tasks:

• The Senior Product Analyst is accountable for supporting Drug Safety and Pharmacovigilance IT and business leadership in implementing IT solutions and strategies.

• The individual will partner with Global Safety Reporting and Signaling business functions and other team members to appreciate key business processes and how to implement technology solutions with GxP compliance.

• The individual will support PV ITrelated projects and has duty & accountability for IT solution implementation and ongoing maintenance.

Minimum Experiences and Skills:

• Minimum 3 to 5 years IT business analyst and/or technical analyst experience

• Has worked with Oracle Argus or equivalent RxLogix PV Suite Spotfire or other reporting tools.

• Strong written and verbal (English) communication skills and cohesive with global colleagues.

• Strong analytical problemsolving documentation presentation organizational influencing and follow up skills.

• Comprehension of business analysis practices and methodologies as well as SDLC.

• Demonstrated ability to succeed in a complex and dynamic work environment.

• Has worked with the business closely and ability to transform business needs into technology requirements.

• Experience collaborating with global cross functional teams.

Preferred Capabilities:

• 2 to 3 years in Pharmaceutical industry experience.

• Knowledge of Research and Development within pharmaceuticals life science industry as well as experience with Global Safety Case Management and Reporting.

• Demonstrated command of Business and IT support for Pharmacovigilance Signal detection Aggregate reporting Case processing ICSR and Analytics.

• Identify and analyze business needs and coordinate between product vendors and other stakeholder groups to deliver prompt efficient and quality support.

• Enhance the business users experience by systematically tracking issues and exploring opportunities to bundle and fix them.

• Support signal evaluation such as adhoc data mining of FAERS VAERS MAUDE and EVDAS databases.

• Familiarity with riskbased monitoring and other industry applications used for Pharmacovigilance.

• Engage and interact with PV and Clinical Data Management stakeholders to comprehend and elicit business requirements such as AE reconciliation.

• Deliver effective and efficient product release rollouts with GxP.

• Provide consultative support on IT deviations and CAPA.

• Triage and identify gaps and find solutions to issues and product bugs.

• Agile Development experience or understanding of agile development

Educational Qualification:

• B.A./B.S. in Engineering Computer Science or similar.

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Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education.

Expected US salary range:

Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and sick days. A summary of benefits is listed here.

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