Description:
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 degree
- Excellent theoretical and proven practical understanding of PV: minimum of 5 years of experience within PV with a focus on QPPV support and Local PV network
- Previous positions as Local Contact Person is desired
- Knowledge 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.