Associate Director, DSPV Data, Technology and Innovation
Insmed Incorporated
August 19, 2026
Remote
United States
IT
Associate Director, DSPV Data, Technology and Innovation
Responsibilities
- Own Insmed’s DSPV safety systems (safety database, signal/risk management tools, safety reporting/analytics) from requirements through implementation, day-to-day use, and retirement.
- Set/approve business requirements, configuration, user access, and release priorities; make final business decisions on trade-offs.
- Manage safety systems and technology vendors: service levels, escalation, issue resolution, product roadmap/release discussions, renewals, and input to contracts/budgets.
- Ensure safety systems capacity/performance/stability as volumes grow; maintain system inventory and audit/inspection documentation.
- Own and refresh the DSPV technology roadmap (build/buy/retire); secure funding.
- Perform PV system gap analyses vs regulatory requirements, portfolio growth, and industry practice; identify improvement strategies.
- Lead evaluation/selection of new safety systems/technologies and manage technology projects end-to-end (scope, schedule, budget, resourcing, dependencies, risks/issues).
- Lead safety data migrations (mapping, reconciliation, verification, legacy decommissioning).
- Lead practical system go-live activities (process design, UAT, training, cutover, post-implementation support).
- Define DSPV reporting/analytics needs; own dashboard/report design and KPI harmonization.
- Enable signal detection, benefit-risk evaluation, and patient exposure analysis via data/tools/access.
- Identify/prioritize AI use cases and manage pilots (define success criteria; decide to scale/adjust/stop); maintain regulatory/AI knowledge.
- Act as the main liaison between DSPV and IT; translate needs to requirements/user stories; incorporate technical constraints back to DSPV decisions.
- Partner with QA on validation/change control inputs; with data platform/enterprise AI teams on shared infrastructure and AI pipeline integration.
- Support inspections/audits and contribute to DSPV SOPs/work instructions/training.
Qualifications
- Bachelor’s degree required (scientific, computational, health-related, or information systems); advanced degree preferred.
- 7+ years biotech/pharma experience; 5+ years working with pharmacovigilance systems, safety data, or PV analytics.
- Required: business/system ownership of industry-standard safety database (e.g., Oracle Argus, ARISg, Veeva Vault Safety); PV safety system implementation and data migrations; project management; vendor management.
- Required: QA collaboration in regulated GxP (computer system validation, UAT, change control).
- Working knowledge of MedDRA, E2B, and global PV regulations (ICH E2A-E2F, GVP modules).
- Ability to evaluate AI/data system build/evaluation and set acceptance criteria.
- Preferred: AI/ML/NLP/RWE experience in PV/clinical development.
- Familiarity with Snowflake/Qlik/Power BI/Tableau and SQL; R/Python/SAS useful.
- Strong analytical/problem-solving; excellent communication; cross-functional collaboration; proficient in Microsoft Office and Adobe Acrobat.
Work Setting
- Fully remote; occasional travel for team meetings/events.
Application Instructions
- Apply via the Jobs Hub in Workday (for current Insmed employees).
- Applications accepted for 5 calendar days from the date posted or until position is filled.
Responsibilities
- Own Insmed’s DSPV safety systems (safety database, signal/risk management tools, safety reporting/analytics) from requirements through implementation, day-to-day use, and retirement.
- Set/approve business requirements, configuration, user access, and release priorities; make final business decisions on trade-offs.
- Manage safety systems and technology vendors: service levels, escalation, issue resolution, product roadmap/release discussions, renewals, and input to contracts/budgets.
- Ensure safety systems capacity/performance/stability as volumes grow; maintain system inventory and audit/inspection documentation.
- Own and refresh the DSPV technology roadmap (build/buy/retire); secure funding.
- Perform PV system gap analyses vs regulatory requirements, portfolio growth, and industry practice; identify improvement strategies.
- Lead evaluation/selection of new safety systems/technologies and manage technology projects end-to-end (scope, schedule, budget, resourcing, dependencies, risks/issues).
- Lead safety data migrations (mapping, reconciliation, verification, legacy decommissioning).
- Lead practical system go-live activities (process design, UAT, training, cutover, post-implementation support).
- Define DSPV reporting/analytics needs; own dashboard/report design and KPI harmonization.
- Enable signal detection, benefit-risk evaluation, and patient exposure analysis via data/tools/access.
- Identify/prioritize AI use cases and manage pilots (define success criteria; decide to scale/adjust/stop); maintain regulatory/AI knowledge.
- Act as the main liaison between DSPV and IT; translate needs to requirements/user stories; incorporate technical constraints back to DSPV decisions.
- Partner with QA on validation/change control inputs; with data platform/enterprise AI teams on shared infrastructure and AI pipeline integration.
- Support inspections/audits and contribute to DSPV SOPs/work instructions/training.
Qualifications
- Bachelor’s degree required (scientific, computational, health-related, or information systems); advanced degree preferred.
- 7+ years biotech/pharma experience; 5+ years working with pharmacovigilance systems, safety data, or PV analytics.
- Required: business/system ownership of industry-standard safety database (e.g., Oracle Argus, ARISg, Veeva Vault Safety); PV safety system implementation and data migrations; project management; vendor management.
- Required: QA collaboration in regulated GxP (computer system validation, UAT, change control).
- Working knowledge of MedDRA, E2B, and global PV regulations (ICH E2A-E2F, GVP modules).
- Ability to evaluate AI/data system build/evaluation and set acceptance criteria.
- Preferred: AI/ML/NLP/RWE experience in PV/clinical development.
- Familiarity with Snowflake/Qlik/Power BI/Tableau and SQL; R/Python/SAS useful.
- Strong analytical/problem-solving; excellent communication; cross-functional collaboration; proficient in Microsoft Office and Adobe Acrobat.
Work Setting
- Fully remote; occasional travel for team meetings/events.
Application Instructions
- Apply via the Jobs Hub in Workday (for current Insmed employees).
- Applications accepted for 5 calendar days from the date posted or until position is filled.