Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency.
Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.
About the Role:
Requires solid experience with pharmacovigilance in Phases I-IV (particularly Phase III) and post-marketing
Reporting to the Executive Director of Clinical Quality Assurance, the Associate Director of Clinical QA – PV Compliance serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/Clinical Departments. The incumbent will provide support and promote collaboration internally and externally to ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines in partnership with Drug Safety and Pharmacovigilance (DSPV) representative.
- This position reports directly to the Executive Director, Clinical Quality Assurance.
- This is a non-supervisory position.
- This role will oversee vendors and/or contractors
Additional representative responsibilities will include, but not necessarily be limited to, the following:
- Facilitate and maintain a risk-based and scientific-based quality system to support Good Pharmacovigilance Practice (GVP).
- Establish and maintain Pharmacovigilance inspection readiness in collaboration with DSPV subject matter expert (SME) and act as company’s representative during regulatory agency inspections and vendor audits.
- Ensure that a risk-based audit plan is developed, designed and implemented, and that the activities are conducted, reports written according to SOPs and that QEs/CAPAs are written, reviewed and followed up.
- Structure and conduct internal Pharmacovigilance systems audits
- Supports the evaluation and acceptability of Pharmacovigilance vendors for potential use and provides direction, guidance and strategicconsultation for the company.
- Conduct external audits on PV vendors, CROs, Specialty Pharmacies and monitoring organizations with responsibility for writing audit reports along with reviewing and monitoring QE’s/CAPAs.
- CQA representative for review of PV SOPs/WIs, PSMF, SDEA’s, JOGs and other PV related documents.
- Supports strategic direction with cross functional working groups to identify and mitigate GVP quality and compliance issues/risks.
- Provide support and training to other staff members to develop additional GVP expertise in quality and auditing resources.
- Minimum BS degree in Chemistry or related life sciences discipline required with minimum 5-7 years of experience, 3 years of which are in Pharmacovigilance.
- Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered.
- Requires solid experience with pharmacovigilance in Phases I-IV (particularly Phase III) and post-marketing.
- Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required.
- Strong knowledge and understanding of drug and device FDA, EU and ICH regulations, pharmacovigilance regulations/processes and HA inspection procedures is required.
- Experience developing SOPs, reviewing internal pharmacovigilance, clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs is essential.
- CQA representative on weekly/monthly pharmacovigilance meetings.
- Ability to organize and conduct internal audits is necessary.
- Ability to conduct external audits on PV vendors, CROs, Specialty Pharmacies and monitoring organizations with responsibility for writing audit reports as well as reviewing and tracking CAPAs.
- Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices and ICH E-6 for Good Clinical Practice.
- Must successfully exhibit Insmed’s five (5) core values of: Passion, Respect, Integrity, Accountability and Collaboration.
- Ability to travel both domestically and internationally, approximately 25%-30%.
- Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.
- Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
- Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.