Senior Specialist, Pharmacovigilance System

This is a fully remote position, open to applicants in India, +1 more country.

📋 Description

• Act as the accountable business system owner for platforms related to Pharmacovigilance (PV), encompassing safety databases, signal management tools, medical information systems, literature monitoring solutions, and reporting platforms.

• Own and oversee the system roadmap, prioritizing enhancements, upgrades, and feature rollouts in line with business strategy and regulatory obligations.

• Lead system lifecycle activities, from defining business requirements and user acceptance testing (UAT) through to deployment and eventual retirement.

• Maintain and govern documentation related to business-owned systems, including Business Requirements Documents (BRDs), functional specifications, Standard Operating Procedures (SOPs), user guides, and validation plans.

• Drive business sign-off and acceptance for modifications, releases, and validation activities pertaining to the system.

• Serve as the primary contact between PV Operations, Medical Affairs, Regulatory, Quality Assurance, and Technical/IT teams.

• Convert business and regulatory needs into actionable technical requirements for developers and vendors.

• Facilitate governance meetings, forums, and working groups.

• Manage relationships with external system vendors and platform providers, including performance reviews, roadmap discussions, and input on contracts.

• Escalate risks, issues, and decisions with a clear framing of their business impact.

• Advocate for best practices, system adoption, and user-centric design as the internal champion for PV systems.

• Lead change management initiatives for system rollouts and upgrades, including communication, training coordination, and stakeholder engagement.

• Represent the PV systems landscape in cross-functional forums, steering committees, and initiatives focused on process improvement.

• Evaluate and promote AI/ML-assisted capabilities in collaboration with the IT department.

• Ensure that systems adhere to global regulatory frameworks such as ICH E2B(R3), EMA EVMPD, FDA requirements, and GVP modules.

• Collaborate with Quality Assurance to maintain validated systems according to GAMP 5, 21 CFR Part 11, and EU Annex 11.

• Provide support during internal and external audits and regulatory inspections.

• Monitor changes in regulations and communicate their impacts on systems to stakeholders.

• Ensure data integrity, traceability, and adherence to audit-trail standards.

• Define, monitor, and report on system Key Performance Indicators (KPIs) and performance metrics.

• Identify and implement process optimizations where workflows intersect with system capabilities.

• Support business continuity planning concerning downtime, data recovery, and disaster recovery.

• Contribute to the strategy for the PV systems portfolio, including evaluations for build/buy/partner decisions and recommendations for technology investments.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Health Informatics, or a related field; a Master's degree is preferred.

• A Bachelor's degree in life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs, or a related field, or equivalent experience is required.

• 3–5 years of experience in Pharmacovigilance, Drug Safety, or a closely related field.

• 4+ years of experience in pharmacovigilance, drug safety, epidemiology, risk management, scientific consulting, regulatory affairs, or a related field is required.

• Proven experience in owning or managing PV systems or technology platforms in a business context.

• Strong knowledge of the complete life science lifecycle, from case intake through aggregate reporting and signal management.

• Experience working in a regulated GxP environment and with validated systems.

• Exceptional cross-functional communication skills, with the ability to translate between business and technology effectively.

• Strong project and program management capabilities; ability to manage multiple system workstreams simultaneously.

• Demonstrated ability to influence without authority across various organizational levels and functions.

• High-level analytical and critical thinking abilities.

• Proficient in requirements gathering, business process mapping, and gap analysis.

• Effective vendor management and negotiation skills.

• Comfortable presenting to and engaging with senior leadership.

• Hands-on familiarity with leading safety databases at the business-user level.

• Understanding of E2B(R3) case data structure, ICSR processing workflows, MedDRA coding, and regulatory submission timelines.

• Experience with PV reporting platforms and dashboards, as well as Power BI or equivalent Business Intelligence tools, and CIOMS and PSUR/PBRER report generation workflows.

• Ability to define and validate KPI reporting requirements in collaboration with data teams.

• Familiarity with signal management platforms and disproportionality analysis (PRR, ROR, EBGM).

• Knowledge of EudraVigilance and FDA FAERS database structures and access protocols.

• Experience with or oversight of systematic literature search tools.

• Understanding of ICSR extraction from literature, deduplication processes, and integration with safety databases.

• Awareness of AI/ML applications, AI-powered literature monitoring, automation, NLP, predictive analytics, LLMs, and responsible AI usage in PV workflows.

• Ability to critically evaluate AI vendor claims and assess technology suitability for regulated PV environments.

• Understanding of AI governance requirements in GxP contexts, including data lineage, explainability, and auditability.

• Familiarity with PV data flows and system integrations, including CRO feeds, affiliate submissions, and E2B gateway connections.

• Knowledge of HL7, FHIR, and E2B XML data standards.

• Comfortable with data mapping, data quality principles, and collaboration with data architects and engineers.

• Basic understanding of API-based integrations and middleware concepts.

• Solid knowledge of GVP Modules I, V, VI, VIII, IX, and XVI.

• Familiarity with GAMP 5, 21 CFR Part 11, EU Annex 11, and CSV/CSA principles.

• Familiarity with ICH E2A, E2B, E2C, E2D, and E2E guidelines.

• Understanding of audit trail requirements, ALCOA+ data integrity standards, and inspection readiness protocols.

• Certification in pharmacovigilance, drug safety, regulatory affairs, clinical safety, quality management, or auditing is preferred.

🏝️ Benefits

• Benefit offerings outside the US may vary by country and will align with local market practices.

• Commitment to equal employment opportunities and non-discriminatory practices in recruiting, training, compensation, benefits, promotions, and transfers.

• Provision of reasonable accommodations during the employment process for individuals with disabilities.