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 EmployerInsmed 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.
Summary
This position is part of the QPPV office team which supports the entire DSPV functions at Insmed. The EMEA LCPPV (Local Contact Person For PharmacoVigilance) Network specialist is responsible for supporting the activities and oversight on the external LCPPV Network in EU, UK and MENA regions. He/she oversees Local PV activities in EMEA and acts as an interface with Insmed DSPV and QPPV to ensure compliance and operational quality. They work closely with the QPPV EMEA and the DSPV global teams. He/she will actively contribute to the improvement of Insmed's Local PV systems and MAH oversight. The role will contribute to the QPPV oversight and help to ensure that Insmed Local PV system complies with the GVPs.
Responsibilities
Responsibilities (Essential Role Responsibilities):Ensure the oversight on the external LCPPV Network in EMEA region including:Review of Local PV plan and propose updates/changes based on Insmed identified needs.Coordinate Insmed review of monthly report with local vendor(s) and partner(s) as per relevant SDEA and as required.Coordinate and attend monthly meetings with local vendor(s) or partner(s) for specific countries if devoted to local PV Activities in EMEA region.Collaborate with local PV Network, the QPPV, QPPV office specialists and relevant global PV roles in the development and management of the local RMPs, local PSMFs and local PV activities and ensure alignment towards the global PV Set-up in Insmed.Support QPPV team in strategic impact assessment of Local PV regulations intelligence items.Develop and maintain an understanding of the global and local country requirements for PV system, applying various regional/local/company templates and ensuring all deliverables are prepared according to regional/local regulatory requirements.Facilitate resolution of Local QE or issues pertaining to the local PV System.Contribute to the development, and maintenance of Insmed´s Local PV system set-up and management of relevant processes and procedures by working closely with local and global stakeholders and assigned Local Network PV Vendor.Act as strategic PV expert in support of DSPVs and/or Insmed Quality documents for PV Network related controlled documents.Facilitate oversight and changes in the PV vendor budget related to the LCPPV Network.Support the QPPV team in general.Support input to the PSMF and the Monthly Oversight Reports in DSPV in general for Local PV activities related to Insmed approved Medicinal Products.Support development and enhancement of the QPPV oversight tools, trainings and processes in Insmed.Position Requirements (Required and/or Preferred Skills, Experience and Education):Education: PharmD, MSc, BS in health or life sciences degreeExcellent theoretical and proven practical understanding of PV: minimum of 5 years of experience within PV with a focus on QPPV support and Local PV networkPrevious positions as Local Contact Person is desiredKnowledge of EU/UK PV regulations and MENA regions: prior experience with European Union (EU) regulations is required. Experience with other regional/local regulations is desired.Broad understanding of relevant EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing PV.Exposure to working relationships with regulatory authorities.Ability to apply problem-solving skills with a focus on detail, quality and collaboration.Excellent oral, written, and interpersonal communication skills, including the ability to lead cross-functional group discussions and meetings.Ability to work independently as well as collaboratively.Ability to independently lead long- and short-term project timelines and deliverables.Strong ability to build relationships and gain the confidence and trust of others through honesty, integrity, and authenticity.Maneuvers comfortably through complex policy, process, and people-related organizational dynamics and operate effectively, even when things are not certain, or the way forward is not clear. Knowledge of and interest in IT systems and databases e.g., Veeva and other IT systems including Microsoft Office applications.Structured and detail oriented, self-driven and able to deliver results.Proficient in verbal and written English with strong written and verbal communication skills. Excellent interpersonal and organizational skills required.Prioritize effectively and work in a matrix team environment required. Travel:Up to 20% travel
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 workHealth benefits and time-off plansCompetitive 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/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. 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.