An established pharmaceutical company is looking for a Drug Safety Manager to join their team based in Surrey, UK.
As Drug Safety Manager, your main role will be to work on the review, analysis, preparation and completion of reports of adverse drug experience to determine the safety profile of the company products. You will need to manage resources in the safety team depending on local organisation and safety group size.
Further key responsibilities of this role will include:
- Organise and manage local PV activities, such as adverse event monitoring, safety reporting, risk management, local safety monitoring activities as required by local agency, local contractual agreements, process documentation and training, inspection preparedness, and any other required country-specific safety activity.
- Manage, where applicable, safety resources in the local team
- Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested
- Ensure complete and timely submission of ICSR to the Core workflow
- Review processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios
- Determine if appropriate case follow-up has been considered
- Consistently apply regulatory requirements and company policies
- Analyse and monitor activities, define and implement corrective actions, where applicable.
- Develop and maintain expertise with advanced knowledge of all assigned products, of applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database
- Provide oversight and team monitoring on case handling aspects, data extraction, and analyses
- Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and/or project lead across all SRM DSU
- Act as subject matter expert for SRM DSU within SRM
- Act as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; and, liaise with key partners regarding safety dada collection and handling
Qualifications and Experience:
The ideal candidate for this Drug Safety Manager position will have the following qualifications and experience:
- Ability to independently solve routine problems related to case processing and surface issues constructively
- Ability to make decisions independently in both routine case processing and unique and/or complex situations, and to resolve issues appropriately to achieve a desired result or impact
- Experience in Pharmacovigilance required
- Solid working knowledge of pharmaceutical concepts
- Understanding and ability to use computer technology, management of relational database systems (specifically ARGUS), including extraction of data
- Strong skills in productivity, organisational and time management in order to meet strict regulatory compliance goals
- Excellent understanding of medical terminology
- Knowledge of global regulations and guidelines for drug development and post marketing activities
- Ability to work independently to accomplish team goals with minimal supervision<p>
- Demonstrated ability to foster teamwork
- Experience of managing technical staff
For more information, or to apply for this Drug Safety Manager position, please contact Hendre Moolman at CK Clinical on Tel: +44 (0)1438 870 023 or email firstname.lastname@example.org quoting 20623 to indicate your interest.