A Drug Safety Manager is required to join an established pharmaceutical company based in Surrey, UK.
In this position you will work on the review, analysis, preparation and completion of reports of adverse drug experience to determine the safety profile of the company products. As Drug Safety Manager, you will need to manage resources in the safety team depending on local organisation and safety group size.
Further key responsibilities of this Drug Safety Manager position will include:
- Organising and managing 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.
- Managing, where applicable, safety resources in the local team.
- Ensuring regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested.
- Ensuring complete and timely submission of ICSR to the Core workflow.
- Reviewing processed cases to verify accuracy, consistency, and compliance with process requirements, and review case data for special scenarios.
- Determining if appropriate case follow-up has been considered.
- Consistently apply regulatory requirements and company policies.
- Analysing and monitoring activities, defining and implementing corrective actions, where applicable.
- Developing and maintaining expertise with advanced knowledge of all assigned products, of applicable corporate and global regulations, guidelines, Standard Operating Procedures and writing practises, of data entry conventions, and of search functions in the safety database.
- Providing oversight and team monitoring on case handling aspects, data extraction, and analyses.
- Leveraging and applying 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.
- Acting as subject matter expert for SRM DSU within SRM.
- Acting as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; and, liaise with key partners regarding safety data 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.
- 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 on Tel: +44 (0)1438 870 023 or email me at firstname.lastname@example.org quoting 20623 to indicate your interest.