Regulatory Affairs Officer SME Safety

Position Purpose:
The IQVIA Regulatory Intelligence online service compiles up to date global regulatory information from more than 110 countries, regions and international organizations to provide the pharmaceutical and medical device industries with easy access to timely alerts for original and translated regulatory documents, expert summaries, and tabulated comparative regulatory information with operational insights.
The Safety Subject Matter Expert role requires extensive knowledge and experience of the EU and worldwide pharmacovigilance/safety reporting requirements gained within a pharmaceutical and/or consultancy environment.
The Safety Subject Matter Expert will collaborate closely with a broad network of internal and external specialists for both maintenance of the pharmacovigilance/safety content within IQVIA Regulatory Intelligence Database and expansion and development of pharmacovigilance/safety content as part of content expansion project teams

Principle Accountabilities:
• Working within cross-functional teams and in collaboration with a network of internal/external regulatory experts. to ensure production and maintenance of high-quality (timeliness, completeness and accuracy) regulatory intelligence related to safety/pharmacovigilance, as per defined QMS processes.
• Providing safety/pharmacovigilance knowledge to support enquiries from customers, sales, marketing and business development.
• Support knowledge sharing and management activities within IQVIA Regulatory Intelligence by providing advice and input on the external regulatory environment
• Proactively input to regulatory content development projects:
o Identify opportunities for content improvement/enhancement projects related to safety/pharmacovigilance
o Contribute to the scope, content identification, user requirements and content creation as well as supporting the QC of the content prior to launch.
o Work in collaboration with other cross-functional team members to design and plan editorial processes and tools to maximize the delivery and quality of regulatory intelligence
• Contribute to raising visibility of IQVIA Regulatory Intelligence services and talent externally (e.g. publications, presentations).

Our ideal Candidate Will Have::
• Proven experience and tenures working in Safety/Pharmacovigilance within Life Sciences (within regulatory authority, consultancy or industry) in the EU/US and other key global markets.
• Degree in life sciences and supplementary education with a safety/pharmacovigilance component would be an advantage
• In-depth knowledge of both pre- and post-marketing safety/pharmacovigilance requirements (individual safety reports and periodic reporting), electronic submissions, risk management plans, signal detection, risk management, qualified person requirements.
• Ability to understand and interpret regulatory developments (guidelines, regulations and laws) to understand, anticipate, interpret and communicate regulatory trends and requirements
• Understand potential impact of regulatory developments on client products and safety/pharmacovigilance business processes
• Experience working in a project environment with demonstrated ability to plan, manage and drive project contributions to ensure delivery of high-quality content in a timely manner.
• Strong attention to detail, proactive and highly organised
• Knowledge of quality management within Life Sciences
• Business understanding/acumen
• Ability to create strong working relationships within the IQVIA Regulatory Intelligence team and across the organization
• Self-motivated, enthusiastic and hard-working
• Strong analytical, organizational and problem-solving skills
• Ability to communicate clearly and effectively (verbally and written) and experience in writing summaries/reports for different audiences
• Knowledge or experience of IT systems, quality (validated systems) and use of regulatory intelligence services within the safety/pharmacovigilance environment would be an added advantage
• Knowledge/experience of safety/pharmacovigilance within other key global/emerging markets and medical device vigilance would be an advantage