Pharmacovigilance Quality and Compliance Lead

Company Description

At Insmed we are on a mission to transform the lives of patients battling serious rare diseases. We are developing novel, targeted therapies to help serve the critical unmet needs of these patients. In concert with developing therapeutic solutions, we are committed to improving the entire patient experience, from diagnosis and treatment to everyday living.

Overview

The PV Quality and Compliance Lead will be responsible for safety and pharmacovigilance activities related to both clinical trials safety and post-marketing safety for Insmed products. The individual will manage governance processes, documentation, training and will lead quality/process improvements and CAPA processes.

Responsibilities

• Oversee PV documentation; maintain PV SOPs and perform reviews/updates to ensure they remain current; also responsible for document archival.
• Manage the review and approval process of PV SOPs and engage the appropriate stakeholders and subject matter experts.
• Oversee safety data exchange agreement process with business partners, if required.
• Lead process improvement initiatives and oversee implementation of necessary changes.
• Ensure compliance with FDA and other relevant health authority regulations/requirements as well as ICH guidelines.
• Ensure PV department is educated in the process of addressing findings (internal or external), including root cause analysis, development of corrective and preventive actions (CAPA) process, and tracking CAPA to completion.
• Ensure that all PV findings undergo proper investigation and remediation, including tracking CAPA.
• Develop and maintain metrics, obtain data, track metrics, and conduct metric review and trending.
• Initiate root cause investigations and develop CAPA for gaps.
• Ensure processes are in place to maintain continuous awareness of evolving PV regulations and lead impact analysis process.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in the life sciences or related area preferred although not required. 
• Minimum 7 years of pharmaceutical experience with a demonstrated focus in PV operations, quality, or compliance.
• At least 2 years in a leadership role with at least 2 years of people management.
• Thorough knowledge of relevant FDA and International Conference on Harmonisation (ICH) guidelines required, including Good Clinical Practices (GCP) guidelines.
• Working knowledge and experience with European pharmacovigilance regulations required
• Thorough understanding of Individual Case Safety Reports (ICSR) processing operations required, including working with outsourced vendors and Contract Research Organizations as well as all steps through case receipt, case processing, medical review and regulatory submission, issuing follow up queries, etc.
• Working knowledge of validated drug safety databases (preferably ARIS-g) and MedDRA.
• Demonstrated project management capabilities and mindset.
• Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.
• Adaptable to changing priorities.
• Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or segments of the organization.