Insmed Incorporated

Manager, Drug Safety & Pharmacovigilance Operations

Location US-NJ-Bridgewater
ID
2021-2220
Job Function
Drug Safety & PV

Company Description

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.

Overview

About the Role:

 

Assists with the oversight of the Drug Safety and Pharmacovigilance Operations Department services and DSPV vendors according to ICH-GCP and GVP guidelines, regulatory requirements, Insmed SOPs, and/or project specific procedures.

This role oversees vendors and/or contractors.

 

Responsibilities

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

  • Liaise cross-functionally and regionally with Biostatistics/Data Management, Clinical Development, Clinical Operations, Clinical Sciences, Commercial, Legal, Medical Affairs, Product Quality, Regulatory Affairs and others as needed to ensure processes are in place for activities performed by those functions that impact full range of PV operational and cross-functional activities.
  • Support hiring, training, mentoring within the DSPV Operations Team.
  • Serve as DSPV Operations Lead for assigned Insmed development programs and organized data collection activities such as Patient Support or Expanded Access Programs (PSPs/EAPs) and Investigator Initiated Trials (ISTs).
  • Support the preparation of periodic safety reports (e.g., PADER, DSUR, PBRER) in accordance with regulatory requirements and standard operating procedures.
  • Liaising with Commercial and Medical Affairs for the Compassionate Use Program and Named Patient Use monitoring and providing applicable updates to safety vendor on a regular basis.
  • Insmed Clinical Study Reconciliation Activities.
  • Provides sponsor oversight of case processing activities by DSPV vendor, including active participation in regular project team meetings.
  • Contributes to key sponsor oversight documents such as the Safety Management Plan, Joint Operation Guidelines (JOG), Data Handling Conventions (DHC), etc.
  • Participating in cross-functional activities to ensure and promote compliance with pharmacovigilance data collection standards and operational consistency across Insmed clinical trials and commercial programs.
  • Assist in managing the safety database activities, including liaison to the safety database vendor, support for issue resolution, maintenance of safety database libraries, initiation of change control, system testing, as applicable, and training.

Qualifications

About You:

  • Bachelor's Degree in one of the life sciences or clinical research and/or a licensed healthcare professional required.
  • Minimum of 5 years of relevant industry experience which includes at least 3 years of drug safety experience.
  • In-depth know ledge of medical terminology and of GCP, ICH guidelines, global drug safety and drug development process, and current US and international pharmacovigilance regulations.
  • Project leadership/management skills.
  • Ability to multi-task and shift priorities quickly while working under tight deadlines.
  • Effective time management and organization skills.
  • Good interpersonal, written, and verbal communication skills.
  • 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 is essential and required.
  • Skilled in developing collaborative internal and external relationships.
  • Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
  • Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing department and company.
  • Must have high degree of professionalism, and ability to work with limited direction.
  • Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.

 

Additional Information

Travel Requirements:

  • Domestic and/or International travel required less than 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.

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