About Insmed:

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:

This position will support the Drug Safety and Pharmacovigilance Operations team with multiple operational day to day activities and DSPV and contract research organizations (CROs) vendor relationships in accordance with ICH-GCP guidelines, regulatory requirements, Insmed SOPs, and/or project specific procedures.

• This is a supervisory position (1-2 direct report[s])

This role will assist the Director of DSPV Operations in the oversight of DSPV vendors and/or contractors

Additional representative responsibilities will include, but not necessarily be limited to, the following: 

• Proactively oversees creation and continuous improvement of adverse event reporting and management processes on a global scale, including the oversight of the case management and regulatory submissions activities within Insmed and DSPV Vendor.
• Oversees the Compassionate Use Program/Named Patient Program (CUP/NPP), Investigator Initiated Research (IIR), and Awareness Trial Use (ATU) processes for safety reporting and maintenance.
• Provides appropriate oversight of the DSPV Vendor performing case management and study support activities including safety database related activities.
• Provides appropriate oversight and assistance for GMP QA Product complaints team as needed
• Collaborates with Regulatory Affairs for any safety information to be submitted to Regulatory Authorities and timely submissions of expedited safety and aggregate reports.
• Oversees the implementation and update of appropriate safety management plans (SMP), Joint Operating Guidelines (JOG), Data Handling Conventions (DHC) with Insmed teams and business partners as required.
• Oversees all reconciliation activities and completion including Specialty Pharmacy, Market Research Vendors, Partners, Clinical Study Reconciliations, etc.
• Identifies opportunities for process efficiencies and participate in process improvement initiatives.
• Assists in management of all critical departmental timelines and with budgets for internal and external spend.
• Assists in the management of invoices and budget related activities for any DSPV Vendors
• Supports oversight and management for all operational aspects of drug safety and pharmacovigilance
• Assists regarding safety vendor management for Vendors, Partners, Specialty Pharmacies, Market Research Vendors
• Assist DSPV Standards and Training and DSPV Medical Safety in the development, review, approval of Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Partners with DSPV Standards and Training as an SME for any vendor CAPA, Deviations, etc.

About You:

• Education: Pharmacy/Nursing/Other health care degree (e.g., BS, MS, PharmD) degree with the equivalent combination of relevant education and professional experience.
• At least 6-8 years relevant pharmaceutical industry experience/expertise, with 4-5 years’ experience in a pharmacovigilance operational position.
• Ability to establish effective working relationships with people in a wide variety of disciplines and backgrounds; manage and prioritize multiple projects and demands simultaneously; rapidly adjust to changing priorities and work effectively under pressure and adherence to timelines.
• Demonstrated knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments.
• Contribute to contractual discussions with potential commercial partners.
• Supervise, manage and triage related Adverse Event and Product Complaint reporting.
• Strong analytical, assessment and problem-solving skills.
• Excellent interpersonal skills and professionalism.
• Ability to lead projects and influence teams.
• Very good and broad understanding of the pharmaceutical industry, and future trends and developments in pharmacovigilance
• Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute PVG department activities.
• Able to develop knowledge of the diseases under study. Able to discuss basic aspects of the disease process with site personnel and colleagues.
• Able to develop knowledge of protocol, regulatory requirements and company SOPs. Conducts activities in alignment with Insmed company values.

Travel Requirements:

• Minimal Domestic travel may be required (up to 25%)
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• 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.