[Hiring] Associate Director, SDEA and Pharmacovigilance Agreements @Insmed Incorporated
Role Description
We’re looking for an Associate Director, SDEA and PV Agreements on the Drug Safety & Pharmacovigilance team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Director, DSPV Operational Excellence and Compliance, you’ll provide expert guidance to internal teams and leadership on regulatory requirements for pharmacovigilance (PV) contractual obligations, ensuring all agreement terms align with DSPV capabilities, quality expectations, and global PV regulations. In this role, you will serve as the functional lead responsible for the strategic development, implementation, and continuous oversight of Safety Data Exchange Agreements (SDEAs), Pharmacovigilance Agreements (PVAs), and PV Clauses (PVCs) within DSPV.
You will ensure that all agreement frameworks are executed with operational excellence, maintained in a state of compliance with applicable regulations, and consistently aligned with evolving company policies and pharmacovigilance requirements.
What You'll Do
• Lead the strategic direction and governance of all DSPV contractual processes, templates and standards surrounding PV Agreements and associate processes.
• Own the entire global strategy for contract lifecycle, including development, review, negotiation, and changes ensuring alignment with compliance framework.
• Establish clear performance expectations, KPIs, and competency frameworks for SME roles.
• Lead, mentor, and develop a team of Subject Matter Experts (SMEs) responsible for drafting, negotiating, and maintaining PVAs and SDEAs.
• Perform detailed contract redlines, reconcile stakeholder feedback, and directly manage the contract lifecycle from intake through execution.
• Draft, review, and negotiate SDEAs, PVAs, Quality Agreements, Scopes of Work, Change Orders, and safety‑related sections in MSAs.
• Ensure all PV agreements meet FDA, EMA, MHRA, ICH, and GVP regulatory requirements.
• Enhance and maintain SOPs, templates, trackers, workflows, and governance tools that support PV contract management.
• Drive continuous improvement, including automation, workflow systems, dashboards, and document management efficiencies.
• Collaborate with Legal, Procurement, Alliance Management, and other internal partners during contract negotiations and issue resolution.
Qualifications
• Bachelor’s degree in pharmacy, nursing, healthcare-related profession or life sciences.
• 4+ years of experience in Pharmacovigilance.
• 4+ years in contract management.
• Proven experience in developing, negotiating, and managing complex PV service agreements including Safety Data Exchange Agreements, and PV Clauses.
• Proficient in financial management, including budgeting, cost control, and resource allocation to optimize operations and meet organizational goals.
• Comprehensive understanding of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH, MHRA).
• Strong negotiation skills with a record of securing favorable terms and conditions.
• Excellent communication and collaboration skills for working with internal stakeholders, regulatory authorities, and external partners.
• Detail-oriented with strong organizational and time management abilities.
• Proficient in Microsoft Office (Word, Excel, PowerPoint).
• Ability to work independently, prioritize tasks effectively, and manage competing deadlines.
• Effective team player with sound decision-making skills within the scope of responsibility, seeking input when necessary.
• Consistently meets deadlines and prioritizes responsibilities, consulting management as needed.
Requirements
• Postgraduate degree (MS, MBA) is preferred.
Benefits
• Comprehensive medical, dental, and vision coverage and mental health support.
• Annual wellbeing reimbursement and access to our Employee Assistance Program (EAP).
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP).
• Company-paid life and disability insurance.
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities.
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back.
Company Description
At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress.
That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.
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We’re looking for an Associate Director, SDEA and PV Agreements on the Drug Safety & Pharmacovigilance team to help us expand what’s possible for patients with serious diseases. Reporting to the Senior Director, DSPV Operational Excellence and Compliance, you’ll provide expert guidance to internal teams and leadership on regulatory requirements for pharmacovigilance (PV) contractual obligations, ensuring all agreement terms align with DSPV capabilities, quality expectations, and global PV regulations. In this role, you will serve as the functional lead responsible for the strategic development, implementation, and continuous oversight of Safety Data Exchange Agreements (SDEAs), Pharmacovigilance Agreements (PVAs), and PV Clauses (PVCs) within DSPV.
You will ensure that all agreement frameworks are executed with operational excellence, maintained in a state of compliance with applicable regulations, and consistently aligned with evolving company policies and pharmacovigilance requirements.
What You'll Do
• Lead the strategic direction and governance of all DSPV contractual processes, templates and standards surrounding PV Agreements and associate processes.
• Own the entire global strategy for contract lifecycle, including development, review, negotiation, and changes ensuring alignment with compliance framework.
• Establish clear performance expectations, KPIs, and competency frameworks for SME roles.
• Lead, mentor, and develop a team of Subject Matter Experts (SMEs) responsible for drafting, negotiating, and maintaining PVAs and SDEAs.
• Perform detailed contract redlines, reconcile stakeholder feedback, and directly manage the contract lifecycle from intake through execution.
• Draft, review, and negotiate SDEAs, PVAs, Quality Agreements, Scopes of Work, Change Orders, and safety‑related sections in MSAs.
• Ensure all PV agreements meet FDA, EMA, MHRA, ICH, and GVP regulatory requirements.
• Enhance and maintain SOPs, templates, trackers, workflows, and governance tools that support PV contract management.
• Drive continuous improvement, including automation, workflow systems, dashboards, and document management efficiencies.
• Collaborate with Legal, Procurement, Alliance Management, and other internal partners during contract negotiations and issue resolution.
Qualifications
• Bachelor’s degree in pharmacy, nursing, healthcare-related profession or life sciences.
• 4+ years of experience in Pharmacovigilance.
• 4+ years in contract management.
• Proven experience in developing, negotiating, and managing complex PV service agreements including Safety Data Exchange Agreements, and PV Clauses.
• Proficient in financial management, including budgeting, cost control, and resource allocation to optimize operations and meet organizational goals.
• Comprehensive understanding of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH, MHRA).
• Strong negotiation skills with a record of securing favorable terms and conditions.
• Excellent communication and collaboration skills for working with internal stakeholders, regulatory authorities, and external partners.
• Detail-oriented with strong organizational and time management abilities.
• Proficient in Microsoft Office (Word, Excel, PowerPoint).
• Ability to work independently, prioritize tasks effectively, and manage competing deadlines.
• Effective team player with sound decision-making skills within the scope of responsibility, seeking input when necessary.
• Consistently meets deadlines and prioritizes responsibilities, consulting management as needed.
Requirements
• Postgraduate degree (MS, MBA) is preferred.
Benefits
• Comprehensive medical, dental, and vision coverage and mental health support.
• Annual wellbeing reimbursement and access to our Employee Assistance Program (EAP).
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP).
• Company-paid life and disability insurance.
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities.
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back.
Company Description
At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress.
That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.
Apply tot his job
Apply To this Job