Manager, DSPV Pharmacovigilance Agreements

Manager, Pharmacovigilance Agreements (Safety & Pharmacovigilance)

Responsibilities:
- Lead end-to-end development, negotiation, implementation, and lifecycle management of Safety Data Exchange Agreements (SDEAs), Pharmacovigilance Agreements (PVAs), and Pharmacovigilance Clauses (PVCs)
- Ensure pharmacovigilance contractual frameworks are executed consistently, maintained in compliance with global regulatory requirements, and aligned with internal policies/operational models
- Serve as subject matter expert for PV contractual obligations and support early identification of DSPV involvement, safety data exchange, inspection readiness, and continuous process improvement
- Develop/implement/maintain SDEAs, PVAs, and PVCs with external partners (e.g., CROs, MAHs, licensors/licensees, distributors, third-party vendors)
- Ensure agreements are executed timely and aligned with ICH E2D, EU GVP Modules, FDA 21 CFR 314, and Insmed procedures
- Maintain centralized tracking/documentation with version control, renewals, amendments, and periodic reviews
- Evaluate incoming/outgoing PV agreement obligations for alignment with contractual commitments
- Identify, assess, and escalate compliance risks/gaps/deviations related to PV contractual obligations
- Monitor KPIs/metrics for PV agreement performance and compliance
- Drive process improvement initiatives to enhance efficiency, consistency, data quality, and compliance across the agreement lifecycle
- Manage PV agreements in SharePoint/designated repositories and maintain the PV Contractual Provision Tracker
- Manage PSMF contractual updates for DSPV Pharmacovigilance Agreements (coordination, comment resolution, and quality control of final drafts)
- Collaborate cross-functionally to resolve PV contract issues, clarify roles/responsibilities, and address operational/compliance challenges

Qualifications:
- Bachelor’s degree in life sciences/clinical research and/or a licensed healthcare professional
- 5 years relevant industry experience, including 3 years of drug safety experience

Skills/Requirements:
- In-depth knowledge of medical terminology; GCP; ICH guidelines; global drug safety and drug development process; US and international pharmacovigilance regulations
- Interpersonal and written/verbal communication skills; experience managing partner relationships
- Ability to handle confidential/sensitive information with discretion, judgment, integrity, and trust building
- Ability to develop collaborative relationships and lead initiatives locally and globally
- Proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
- Ability to independently plan/organize work and manage multiple priorities
- Personal accountability and strong judgment for escalation when needed
- Ability to build/maintain relationships and handle tough challenges professionally

Preferred/Additional (if applicable):
- High professionalism; self-motivated with initiative, ownership, and follow-through on tasks

Travel/Work Location:
- Fully remote; occasional travel (~20%) for team meetings/events

Application Instructions:
- Applications are accepted for 5 calendar days from the date posted or until the position is filled.
- Current Insmed employees: apply via the Jobs Hub in Workday.