Insmed Incorporated Hiring for Assoc Director, DSPV Safety Scientist job in Bridgewater Full Time

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 and 2022

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 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 BiopharmaTM List, Small and Medium, and one of the Best Workplaces in New YorkTM, which recognizes companies headquartered in NY, NJ, and CT.

Overview

The Associate Director Safety Scientist (ADSS), Drug Safety and Pharmacovigilance (DSPV) is responsible for the safety expertise of assigned developmental and/or marketed products in conjunction with the Medical Safety Leads (MSL) and Safety Physicians (SP). This includes representing the department internally and externally at a global level and functioning as a member of relevant project/study teams. The position will lead the DSPV Medical Safety Scientists’ activities including but not limited to interfacing with designated vendors/CROs, managing signal evaluation/safety monitoring activities, contribute and assist in pharmacovigilance activities including benefit/risk assessments, individual or aggregate review and reporting of safety data from various sources in support of regulatory aggregate reporting requirements and participating in regulatory activities and interactions.

Responsibilities

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

• Support the MSL in the safety review process and evaluation of safety data throughout the product lifecycle using quantitative and qualitative approaches.
• Responsible for project management, authoring, and reviewing high quality aggregate periodic safety reports including DSUR, PBRER, PADER, SUSARs, Line Listing Reports to meet internal deadlines and regulatory timelines and ad hoc reports in collaboration with the MSL and SP.
• Responsible for drafting the safety sections in collaboration with the MSL and SP on regulatory responses, IBs/RSI/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, and providing the necessary quality control to ensure alignment with core safety position.
• Ensure all safety regulatory documents are processed and submitted according to regulatory requirements and timelines.
• Draft and/or review critical documents produced for regulatory agency safety inquiries in terms of scientific content and alignment with company position, clarity, accuracy, and consistency and facilitate document review by other contributors.
• In collaboration with the MSL and/or SP, write and maintain core RMPs and local Risk Management Plans/REMS; assist with responses to Regulatory inquiries under the guidance of the MSL and SP.
• Review publications from the scientific and medical literature for important safety information; summarize and critically appraise the findings from these publications for safety reports (such as periodic safety update reports, signal detection reports, and signal evaluations.
• Coordination of operational meetings of ongoing cross functional safety review team meetings and conduct analysis of safety data for products in designated therapeutic areas.
• Assist designated safety vendors in obtaining follow-up information for individual cases and ensuring appropriate feedback from Global Clinical and Safety Leads. Participates with Insmed DSPV Medical Safety in providing oversight of designated CROs and Vendors.
• Participation with DSPV inspection readiness activities in collaboration with the Senior Director of Operations Standards and Training and Insmed Quality Assurance.
• Interface with other Insmed functional groups such as Regulatory Affairs, Clinical Development, Medical Affairs, Clinical Quality Assurance, business units, as needed.
• Contribute to quality improvement of on-going process enhancement for DSPV such as developing local and global standard procedures and templates.
• Preparation for Signal Detection Activities including data collection, analysis of data, and write the safety signal detection and assessment reports.
• Participate in Clinical Study reconciliation activities for different products and collaboration with Insmed Data Management and vendor as needed.
• Contributes to and has oversight of documents such as the Safety Management Plan(s), Joint Operation Guidelines (JOG), Data Handling Conventions (DHC), etc.
• Assist in the internal and external dissemination of important new safety information or actions (e.g. DHCP/DHPC letters)
• Oversight and review of MedDRA with support of vendor
• Manage, train and/or support junior safety scientists and interns; contribute to investigator training, departmental processes, and inspection readiness.
• Participate in other safety activities as needed.

Qualifications

• Bachelor’s degree in pharmacy, nursing or other health care related profession or life sciences required. Advanced degree in relevant discipline preferred e.g. PharmD or PhD
• Additional MPH (Master of Public Health) or master’s in business administration (MBA) or Healthcare Administration is a plus.
• Minimum 7 years in Drug Safety/Pharmacovigilance in pharmaceutical industry setting with both investigational and marketed products
• At least 4 years of experience with medical case reviews, aggregate safety reporting, safety surveillance, signal management and/or Risk management
• Practical examples of end-to-end project management within Drug Safety/PV or relevant 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
• Active participation in regulatory inspections is a plus
• Ability to review and or prepare, scientific or regulatory documents, from large volumes of scientific information
• 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.
• Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
• Must successfully exhibit Insmed’s five (5) core corporate values of: Respect, Passion Integrity, Collaboration, Accountability, along with any other position specific competencies.
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
• Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing department and company with a 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

Travel Requirements

Domestic and/or International travel required (10 %)

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 $140,000.00 to $200,000.00 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.