Sr Director, Medical Safety
Insmed Incorporated

Job Info

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Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

Named Science's 2021 Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's 2021 Top Employers Survey.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2022, we became Great Place to Work-certified in the U.S. for the second year in a row. In 2022, we were also listed as the No. 2 company on the Best Workplaces in Biopharma TM List, Small and Medium, and one of the Best Workplaces in New York TM , which recognizes companies headquartered in NY, NJ, and CT.

Overview

Medical Safety Lead for assigned Insmed projects or products throughout the product life cycle (investigational and marketed), providing global clinical/scientific/PV leadership and strategic input into all aspects of drug safety and pharmacovigilance, while ensuring compliance with US and international PV regulation.

• This is a supervisory position (direct/in-direct reports)
• This role oversees vendors and/or contractors

Responsibilities

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

• Manage the relationship with Pharmacovigilance providers, Clinical Study CROs and internal Medical, Safety and Clinical personnel
• Contribute to the development, production and maintenance of the appropriate tracking and compliance tools, reports, plans, tasks, and activities pertaining to the management of other pharmacovigilance activities.
• Collaborate with safety physicians, medical monitors, toxicology group, and other functional groups in identification, analysis, and reporting of possible trends or concerns
• Escalate concerns and interact with the Executive Safety Committee (ESC) in collaboration with the ED-DSPV and EU QPPV
• Contribute to development & maintenance of product safety profile
• Support and/or draft regulatory inquiry responses related to pharmacovigilance / safety issues to regulatory agencies, EC/IRB, Investigators and ad hoc inquires
• Track events of special interest and assist in development and maintenance of standardized queries for events of special interest
• Provide input and review to key regulatory or clinical documents (i.e. clinical study reports, investigator brochures, integrated summaries of safety, aggregate safety reports, RMP) related to pharmacovigilance
• Perform follow-up on pending Corrective and Preventive Actions (CAPAs) and ensure implementation of the same in the Global compliance database
• Oversee compliance data analysis using available tools to identify potential trends
• Direct literature search and review and able to effectively determine appropriate and relevant literature for the purpose of safety analysis
• Support the conduct of PV audits/regulatory inspections
• Participate in the development of compliance programs and quality tools to enhance global quality and adherence to SOPs and Regulations
• Participate in internal pharmacovigilance committee meetings as well as joint safety meetings with partners
• Provide oversight and direction to direct reports, empowering them to take responsibility for their individual job functions; follow organizational processes and leverage performance and development programs to assist with guidance

Qualifications

• MD (US or Internationally trained) required, preferably board certified in internal medicine, MPH (Masters of Public Health) is a plus
• Minimum 10 years of experience in pharmacovigilance activities is required; working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments (including ICH/CIOMS, Clinical development methodology and knowledge of Clinical Trial guidelines (GCP) and regulation) is essential
• Working knowledge of MedDRA dictionary is necessary
• Familiarity with common Safety databases (e.g. ARGUS, etc.) is preferred
• Knowledge of Individual Case Safety Reports (ICSR) management processes including case receipt, case processing, medical review, and regulatory submission
• Ability to read and collate scientific and medical literature is also required
• Proven ability to work on multiple projects
• Excellent computer skills: email and Internet and Adobe Acrobat are required
• Action orientation combined with high ethical standards is critical
• Efficiency, detail-oriented orientation, flexibility, and the ability to meet tight deadlines is essential
• Excellent communication (verbal and written), organizational, planning, and follow-up skills are needed
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
• Must exhibit Insmed's organizational values and global leadership competencies
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace

Travel Requirements

Domestic and/or International travel required (15 %)

Additional Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

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.

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