Senior Business Analyst - Lifesciences CRM at Valsoft Corporation

Lisbon, , Portugal -

Full Time

Start Date

Immediate

Expiry Date

20 Jan, 26

Salary

0.0

Posted On

22 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Business Analysis, FDA Regulations, CRM Implementations, Data Privacy, Regulatory Compliance, Business Process Reengineering, User Acceptance Testing, Pharmaceutical Sales, Market Data Analysis, Cross-Functional Collaboration, Communication Skills, Requirements Management, Solution Design, Project Management, Leadership

Industry

Financial Services

Description

Position Overview The Senior Business Analyst – Pharmaceutical is a pivotal client-facing role responsible for driving business transformation initiatives within leading pharmaceutical companies. This position requires deep expertise in FDA regulations, including 21 CFR Part 11, PDMA, and the Sunshine Act, GDPR and Data Privacy, Cross border data transfer rules, and a comprehensive understanding of Europe pharmaceutical sales and market data. The successful candidate will lead cross-functional teams in CRM implementations, business process reengineering, and regulatory compliance projects. Key Responsibilities · Lead requirements elicitation sessions with business and techno-functional stakeholders, ensuring thorough documentation and alignment with project objectives. · Design and optimize business processes to enhance efficiency and compliance with FDA regulations, including but not limited to 21 CFR Part 11, PDMA, the Sunshine Act, State-Level Regulations, Awareness of AMA Data Restrictions Programs, HIPAA, GDPR, and CCPA for data privacy and physician data protection. · Engage in business requirement-oriented conversations in context with Europe pharmaceutical market data sources (IQVIA) while ensuring compliance with data privacy and physician opt-out programs. · Serve as a functional leader in solution design, collaborating closely with IT and business teams to deliver scalable and compliant platforms. · Coordinate and oversee User Acceptance Testing (UAT), ensuring solutions meet business requirements and regulatory standards. · Analyze Europe pharmaceutical sales and market data to provide actionable insights for business strategy and decision-making. · Contribute to pre-sales activities and RFP responses, articulating solution value and regulatory expertise to prospective clients. · Maintain current knowledge of regulatory changes and industry trends, proactively advising clients and internal teams. · Foster cross-functional collaboration, acting as a bridge between business units and technical teams throughout the project lifecycle. · Bachelor’s degree in Business, Computer Science, Life Sciences, or related field. · Minimum 10 years of client-facing experience in the pharmaceutical industry, with a proven track record in business analysis. · Demonstrated leadership in CRM implementations, preferably with Dynamics 365, including project management and team coordination. · Expert-level understanding of FDA regulations (21 CFR Part 11, PDMA, Sunshine Act) and their application to pharmaceutical business processes. · Comprehensive knowledge of Europe pharmaceutical sales, market data, and data providers. · Should have knowledge of commonly leveraged data by pharmaceutical companies in the US to optimize sales targeting, measure marketing ROI, ensure regulatory compliance, and drive strategic decision-making. Should have knowledge of data sets (most if not all) such as Prescription Sales Data, Prescriber-Level Data, Patient-Level Data (de-identified), Pharmacy Dispensing Data, Formulary Access Data, Hospital Sales Data, Physician Target Lists, Call & Sample Activity Data, Detailing Activity Data, Speaker Program Attendance Data, Promotional Spend Data, Digital Engagement Metrics (webinars, emails, websites), Social Media Engagement Data, KOL (Key Opinion Leader) Sales Force Alignment Data, Territory Performance Data, Account Management Data, CRM Interaction Data, HCP (Healthcare Professional) Segmentation Data, Compliance Monitoring Data, State-Level Marketing Restriction Data, Sunshine Act Reporting Data, Sample Distribution Data, ROI Analysis Data. · Strong experience in business process reengineering and regulatory compliance projects. · Exceptional communication skills, including the ability to convey complex functional and regulatory concepts to diverse audiences. · Proficiency in requirements management, documentation, user story development, solution design, and UAT coordination. Regulatory and Compliance Focused Requirements in EU · GDPR & Data Privacy Compliance: Proven understanding of General Data Protection Regulation and its impact on CRM data handling, consent management, and customer profiling within pharmaceutical commercial operations. · Pharma Promotion & Transparency Regulations: Familiarity with industry codes such as European Federation of Pharmaceutical Industries and Associations (EFPIA) disclosure and transparency requirements, including rules on HCP/HCO engagement and reporting. · Electronic Records & Signature Controls: Working knowledge of controls aligned with EU Annex 11 and 21 CFR Part 11, ensuring electronic records, signatures, and audit trails in the CRM are compliant and validated. · Regulatory Audit & Inspection Readiness: Experience gathering, structuring, and documenting functional and regulatory requirements to support audits, inspections, and traceability across CRM processes. · Data Retention & Cross-Border Data Transfer Rules: Understanding of EU data localization, retention policies, and lawful transfer mechanisms to ensure CRM configurations align with local and cross-border compliance obligations. Paid Time Off Training & Development

Responsibilities

The Senior Business Analyst will lead business transformation initiatives within pharmaceutical companies, focusing on CRM implementations and regulatory compliance projects. This role involves engaging with stakeholders to document requirements and optimize business processes in line with FDA regulations and data privacy laws.