Medical Safety Lead
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 Top Employer in 2021, 2022, and 2023

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 Top Employers Survey for two years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.

Overview

The Medical Safety Lead is the DSPV expert for assigned products; maintains current knowledge of assigned product portfolio and safety profiles for products. He/she is responsible for safety surveillance, risk management, and risk communication for assigned development and marketed products as well as medical assessment of individual adverse event reports, generation, and review of aggregate reports and safety documents, including labeling changes. This role provides DSPV support for internal and external customer.

Responsibilities

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

• Responsible for appropriate review of all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products and development compounds
• Responsible for conducting safety signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information
• Leadership of the Safety Review Team(s) for assigned products and development compounds, and responsible for the management of ongoing and cross functional assessment of benefit risk profiles and related actions, including writing and updating of the benefit-risk documents for assigned products and development compounds
• Provides medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs).
• Works with the Head of DSPV to develop the strategy and implementation of safety and benefit-risk management for assigned products.
• Responsible for key content of Risk Management documents (RMPs, REMS) of assigned products.
• Provide input into and support the writing of periodic reports for assigned products; provide medical interpretation, review and approval for required reports.
• Share DSPV and medical expertise with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
• Provide expert safety input to the clinical development program for assigned products and development compounds • Responsible for adequate and up to date representation of safety information in Company Core Data Sheet and Investigator Brochure, and other labeling documents
• Ensure, in collaboration with Regulatory Affairs labeling team an accurate representation and communication of the safety profile of assigned products and development compounds
• Responsible for responses to inquiries from regulatory authorities on safety issues
• Provide integrated safety input into all regulatory documents where required
• Perform thorough assessment of safety profiles for Due Diligence project
• Provide Drug Safety input for product recall issues or Health Hazard Evaluations and Dear Healthcare Professional letters
• Perform and or provide oversight of the medical review of all adverse event reports for seriousness, expectedness and causality
• Assist PV Scientists and designated safety vendors with medical opinion on obtaining follow-up information for individual cases.
• Participate in review of scientific literature: identify case reports that meet criteria for entry into the safety database; identify relevant safety articles / references involving the active ingredients of marketed products and products in development; and create literature summary sections to be included in PSURs and other required reports.

Qualifications:

• MD. or D.O (US or Internationally trained) preferred; MPH (Masters of Public Health) is a plus
• At least 2 years of Clinical Patient Care experience preferred
• At least 5 years of experience in pharmaceutical industry within Drug Safety/Pharmacovigilance with both investigational and marketed products
• Ability to review and or prepare, scientific or regulatory documents, from large volumes of scientific information Knowledge and understanding of national & international PV and regulatory guidelines
• Presenting drug safety topics for regulatory authorities or at conventions, meetings, etc. Product defense before a national or international regulatory authority a plus
• Drug safety database knowledge preferred
• Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat computer skills
• Must have excellent communication skills (verbal and written)
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Must successfully exhibit Insmed's five (5) core corporate competencies of: Excellence,
• Accountability, Driven, Collaborative and Solutions; along with any other position specific competencies.
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Qualifications

• MD. or D.O (US or Internationally trained) preferred; MPH (Masters of Public Health) is a plus
• At least 2 years of Clinical Patient Care experience preferred
• At least 5 years of experience in pharmaceutical industry within Drug Safety/Pharmacovigilance with both investigational and marketed products
• Ability to review and or prepare, scientific or regulatory documents, from large volumes of scientific information Knowledge and understanding of national & international PV and regulatory guidelines
• Presenting drug safety topics for regulatory authorities or at conventions, meetings, etc. Product defense before a national or international regulatory authority a plus
• Drug safety database knowledge preferred
• Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat computer skills
• Must have excellent communication skills (verbal and written)
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Must successfully exhibit Insmed's five (5) core corporate competencies of: Excellence,
• Accountability, Driven, Collaborative and Solutions; along with any other position specific competencies.
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Travel Requirements

Up to 5% travel based on vendor requirements

Salary Range

Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.

The base salary range for this job is from $244,000.00 to $292,000.00 per year

Compensation & Benefits

We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

• Flexible approach to where and how we work
• Competitive compensation package including bonus.
• Stock options and RSU awards
• Employee stock purchase plan
• 401(k) plan with company match
• Professional Judgment Vacation Policy
• 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day).

ADDITIONAL U.S. BENEFITS:

• Medical, dental, and vision plans
• Company-provided short- and long-term disability plans
• Company-provided life insurance
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity plans
• Supplemental AD&D
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• On-site, no-cost fitness center at our U.S. headquarters
• Paid time off to volunteer

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.

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.

Applications are accepted until the position is filled.

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