IQVIA Hiring PV Literature Surveillance Expert
IQVIA Hiring PV Literature Surveillance Expert
About the job
- Ensure Literature processes for Consumer Healthcare products are implemented as per regulations
- Oversees the vendor who provides daily end-to-end literature screening/searches of global products registered in by customer, and other acquired entities and requests for articles and translations; oversees vendor’s triaging of abstracts/articles for case/non-case buckets; and oversees vendors selection of non-case articles which might be included into the customer safety surveillance process;
- Is the primary Liaison with the technology team responsible for the literature screening platform and for developing new literature search strategies; provides direction as appropriate to vendor on performing ad hoc literature searches as requested by Pharmacovigilance personnel;
- Accountable to provide training on the customer literature screening tool to new Pharmacovigilance employees describing the literature screening process and the ad hoc literature request process;
- Supports the global outsourcing and vendor management team by facilitating discussions with local country affiliates for the transfer of local literature screening activities to the company global literature screening process;
- Maintains and updates literature related quality documents;
- Remain current on with evolving regulations concerning literature surveillance (ex ICH); ensure customer’s literature screening activities are in compliance with global regulations;
- SME for internal/partner audits and inspections;
- Performs documented quality checks on vendor activities according to customer quality documents
- Other activities as assigned
