Manager, DSPV Pharmacovigilance Agreements

About the role

We're seeking a Manager, Pharmacovigilance Agreements on the Drug Safety & Pharmacovigilance team. This role involves leading the development, negotiation, implementation, and maintenance of Safety Data Exchange Agreements (SDEAs), Pharmacovigilance Agreements (PVAs), and Pharmacovigilance Clauses (PVCs). Key responsibilities include ensuring these agreements are executed in compliance with global regulatory requirements and aligning with Insmed's internal policies and operational models.

Responsibilities

• Lead the development, negotiation, implementation, and maintenance of SDEAs, PVAs, and PVCs with external partners.
• Ensure agreements are executed in a timely manner and aligned with applicable global pharmacovigilance requirements.
• Maintain centralized tracking and documentation of all PV agreements, ensuring appropriate version control, timely renewals, amendments, and periodic reviews.
• Evaluate incoming and outgoing PV Agreement obligations to ensure alignment with contractual commitments.
• Identify, assess, and escalate compliance risks, gaps, or deviations related to PV contractual obligations.
• Support the monitoring of KPIs and metrics related to PV agreement performance and compliance.
• Drive process improvement initiatives that enhance efficiency, consistency, data quality, and compliance across the PV agreement lifecycle.
• Manage PV agreements within SharePoint or designated repositories and maintain the PV Contractual Provision Tracker.
• Manage PSMF contractual updates on behalf of DSPV Pharmacovigilance Agreements including coordination, comment resolution, and quality control of final drafts.
• Collaborate with cross-functional stakeholders to resolve PV contract-related issues, clarify roles and responsibilities, and address operational or compliance challenges throughout the agreement lifecycle.

Requirements

• A Bachelor’s Degree in one of the life sciences or clinical research and/or a licensed healthcare professional with 5 years of relevant industry experience, including 3 years of drug safety experience.
• In-depth knowledge of medical terminology and of GCP, ICH guidelines, global drug safety and drug development process, and current US and international pharmacovigilance regulations.
• Good interpersonal, written, and verbal communication skills and experience in managing partner relationships.
• Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings.
• Skilled in developing collaborative internal and external relationships and able to lead initiatives locally and globally.
• Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
• Able to independently plan and organize own work and effectively manage multiple priorities and responsibilities.
• Demonstrated personal accountability for taking actions that drive business decisions.
• Sound judgment in knowing when to escalate issues and able to make sound decisions in absence of Manager.
• Able to build and maintain relationships with peers and superiors, recognize impact of work on other functional areas, and embrace tough challenges with confidence, enthusiasm, and optimism.

Qualifications

• Highly organized and detail-oriented with strong analytical and problem-solving skills.
• Experience in regulatory affairs, pharmacovigilance, or related fields.
• Ability to work independently and as part of a team.
• Knowledge of regulatory requirements and standards in the pharmaceutical industry.
• Experience with contract management systems and tools.

Skills

• Excellent written and verbal communication skills.
• Strong negotiation and conflict resolution skills.
• Proficiency in MS Office applications.
• Ability to manage multiple projects simultaneously.
• Strong attention to detail and accuracy.

Benefits

Insmed offers comprehensive benefits including medical, dental, and vision coverage, mental health support, and generous paid time off policies. We also provide fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration.

Pay

$133,000.00 - $173,000.00 Annual

Schedule

This is a fully remote role. Occasional travel for team meetings or events will be expected.