Manager, DSPV Operations & Vendor Management

BioSpace

Bridgewater (MA)

On-site

USD 119,000 - 167,267

Full time

14 days+

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Benefits offered by this job

Flexible work approach

Health benefits

Competitive compensation package

Equity Awards

Employee Stock Purchase Plan

Job summary

A leading company in the biopharma industry is looking for a Manager of DSPV Operations & Vendor Management. This role involves ensuring compliance with drug safety regulations and managing vendor relationships. Candidates should possess a Bachelor’s degree in life sciences and have significant experience in drug safety operations. Join an industry-recognized employer committed to a patients-first mentality and operational excellence.

Qualifications

Minimum of 5 years of relevant industry experience, including at least 3 years in drug safety.
In-depth knowledge of GCP, ICH guidelines, and pharmacovigilance regulations.
Experience managing vendor relationships and quality checks.

Responsibilities

Oversee PV Vendor and manage quality check activities.
Create and track Key Performance Indicators for vendor performance.
Liaise with cross-functional stakeholders to enhance PV operational processes.

Skills

Interpersonal Skills

Communication

Problem Solving

Analytical Skills

Education

Bachelor's Degree in Life Sciences or Clinical Research

Tools

MS Office

Job description

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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

Consistently Ranked Science's 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've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma, Best Workplaces in New York, PEOPLE Companies That Care, Best Workplaces for Women, Best Workplaces for Millennials, and Best Medium Workplaces lists.

Overview

Supports the oversight of the Drug Safety and Pharmacovigilance Operations and Vendor Management activities as well as DSPV business partner relationships ensuring compliance with ICH-GCP and GVP guidelines, regulatory requirements, Insmed SOPs, and/or project specific procedures.

Responsibilities

Support the oversight of PV Vendor through management of Quality Check (QC) activities related to ICSR processing, regulatory reporting, and follow-up.
Create, track, monitor Key Performance Indicators (KPIs) and metrics for vendor performance monitoring.
Identify and address any gaps in vendor case management processes.
Serve as the primary liaison and point of contact with internal cross-functional stakeholders (QA, Patient Safety, Compliance, Commercial Strategy, Medical Affairs) to enhance PV Operational processes to ensure seamless cross-functional integration.
Oversee and manage correspondence from PV Vendor and PV Related vendors to promptly resolve inquiries related to evaluation and processing of ICSRs.
Contribute to the enhancement of Insmed's Pharmacovigilance System Master File (PSMF) improvement by collaborating on procedures to ensure comprehensive collection, management and reporting of case reports from all sources per Study Safety Management Plans (SMP) and Standard Operating Procedures (SOPs).
Support the updates of DSPV Operations Controlled Documents.
Manage the ongoing review, update and alignment of DSPV operational documents: Joint Operating Guideline (JOG), Data Handling Conventions (DHC), Monthly Operational Report (MOR), and Safety Surveillance Forms (SSF).
Provide operational support for cross-functional DSPV requests/investigations including those related to Patient Services, QA, PV, Legal, ensuring compliance with PV processes.
Manage updates and oversight for PV-related activities associated with Expanded Access Programs (EAP), Compassionate Use Programs (CUP) and Post Trial Access Program (PTA) updates to ensure compliance with reporting obligations.
Collaboratively manage the quarterly Insmed DSPV newsletter overseeing updates and publication to enhance communication and awareness in the DSPV team.
Collaboratively support Insmed's clinical study electronic Trial Master Files (eTMF) to ensure PV-related documents are properly quality checked, archived and accessible.
Enhance DSPV inspection readiness through the development of problem-solving strategies related to ICSR processing, aggregate reports, such as root cause analysis and CAPA development.
Facilitate the onboarding, training and mentorship of new hires within the DSPV Operations and Vendor Management Team ensuring they develop a strong understanding of pharmacovigilance processes, regulatory requirements, and vendor oversight best practices to drive operational excellence.Position Requirements (Required and/or Preferred Skills, Experience and Education):
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 knowledge of medical terminology and of GCP, ICH guidelines, global drug safety and drug development process, and current US and international pharmacovigilance regulations.
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.
Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Leads initiatives locally and globally.
Independently plans and organizes own work and effectively manages multiple priorities and responsibilities.
Demonstrates personal accountability for taking actions that drive business decisions.
Displays sound judgment in knowing when to escalate issues. Makes sound decisions in absence of Manager.
Builds and maintains relationships with peers and superiors.
Recognizes impact of work on other functional areas and interdependencies.
Embraces tough challenges with confidence, enthusiasm, and optimism.
Must have 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.
Flexible mindset.

Salary Range

$119,000 - $167,267 a year

Compensation & Benefits

At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

Flexible approach to how we work
Health benefits and time-off plans
Competitive compensation package, including bonus
Equity Awards (Long-Term Incentives)
Employee Stock Purchase Plan (ESPP)

For more information on U.S. benefits click here.

Additional Information

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. 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.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview 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.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.

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