drjobs Associate Director, PV Regulatory Intelligence

Associate Director, PV Regulatory Intelligence

Employer Active

1 Vacancy
drjobs

Job Alert

You will be updated with latest job alerts via email
Valid email field required
Send jobs
Send me jobs like this
drjobs

Job Alert

You will be updated with latest job alerts via email

Valid email field required
Send jobs
Job Location drjobs

Dublin - Ireland

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Provide Global Regulatory Intelligence for Clinical and Post approval Pharmacovigilance for LCS and LCS Customers.

Responsibilities

  • Review and scan Regulatory and organizations websites for Regulatory Intelligence for Clinical and Post approval Pharmacovigilance in line with IQVIA procedures.

  • Proactively monitor ICH GVP CIOMs and key agencies for draft legislation supporting consultation opportunities where available

  • Entry and Quality Review of Global PV Regulatory Intelligence into IQVIAs Regulatory Information Database

  • Collaborate with IQVIAs EU and Local QPPV network and local offices to collate data.

  • Support Lifecycle Safety with RFI RFP and BD activities

  • Build and maintain Commercial Model for provision of PV Regulatory Intelligence to LCS Customers

  • Collaborate with LCS departments to understand PV deliverables to ensure corresponding Regulatory Intelligence is available.

  • Assess potential impact of regulatory changes on process or deliverables in collaboration with functional SMEs and/or Process excellence

  • Liaise with Business Development on proposal feasibility

  • Lead bid defense strategy and planning for Regulatory Intelligence offering

  • May act as primary interface for customers

  • Attend internal and customer meetings

  • Lead or support continuous improvement initiatives for processes and infrastructure

  • Lead or support implementation of innovative process tech or AI for continual improvement.

  • Support Lifecycle Safety Audits and Inspections

  • Cross functional collaboration

  • Provide coverage for Reg intelligence colleagues during absences

  • Mentor train and/or provide support and guidance to junior team members and peers

Minimum Required Education and Experience

  • Experience:Minimum 57 years of relevant Pharmacovigilance experience

  • Education:Bachelors degree (preferably in health science or related field)

  • Additional Experience:

    • 5-7 years of relevant Pharmacovigilance experience

    • At least 3 years of experience with assessing global PV Regulatory Intelligence

    • 5 years in Lifecycle Safety (e.g. Pharmacovigilance CEVA Medical Info Safety Publishing Risk Management)

    • Equivalent combinations of education training or experience accepted

    • Practical knowledge of Global PV Regulations

Skills and Abilities

  • In-depth knowledge of Safety service lines ICH guidelines GVP modules and regional requirements

  • Ability to gather and interpret regulatory information

  • Strong business acumen financial management

  • Proven leadership and motivational skills

  • Strategic planning project management and organizational skills

  • Ability to manage multiple delivrables and priorities

  • Effective communication with senior stakeholders

  • Calm assertive and diplomatic in challenging interactions

  • Excellent verbal written presentation and negotiation skills

  • Strong customer focus and account management

  • Networking and meeting leadership skills

  • Results-driven in matrix environments

  • Creativity innovation and problem-solving

This role is not available for a UK visa sponsorship.

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at


Required Experience:

Director

Employment Type

Full-Time

About Company

Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.