Associate Director, PV Regulatory Intelligence
IQVIA
**Provide Global Regulatory Intelligence for Clinical and Post approval Pharmacovigilance for LCS and LCS Customers.**
**Responsibilities**
**Review and scan Regulatory and organization’s 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 IQVIA’s 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 5–7 years of relevant Pharmacovigilance experience**
**Education:** **Bachelor’s 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 https://jobs.iqvia.com
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
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