Associate Director, PV Regulatory Intelligence
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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
Key Skills
- Program assessment
- FDA Regulations
- Manufacturing & Controls
- Program Evaluation
- budget forecast
- Research Experience
- Operations Management
- Research & Development
- Strategic Planning
- Contract Management
- Leadership Experience
- negotiation
About Company
Solutions to help life sciences organizations drive healthcare forward and get the right treatments to patients, faster.
