Description
Patient Safety Manager - R&D/Medical/Clinical/compliance - london
Location - London, UK
We have an excellent role with one of our life science clients.
Responsibilities
- Performs with little or no supervision the required pharmacovigilance/patient safety activities listed below in line with local regulatory and relevant legal requirements and client procedures.
- May take overall responsibility to manage either the PV function or the PV team (people management) for the assigned local affiliate. Acts as PV Responsible in the absence of Head of Patient Safety of the Country/Hub where required.
- Provides guidance to team members, where required, and assists the Head of Patient Safety in the day-to-day management of the local Patient Safety function.
- Risk management plans
- Provision of safety information
- Implementation of PV Audit and Inspection Readiness
- Planning, processing, and reporting of Aggregate Reports to HA and EC (as required)
- Maintenance of PV Awareness and Training
- Implementation of Pharmacovigilance Agreements
- Collection, follow-up, and forwarding of spontaneous, literature, solicited, post-marketing AE cases (as applicable)
- Submission of single cases to local Health Agencies(HA) and Ethics Committees (as required)
- Local Market Safety Data Quality.
Desired Experience
- University degree (preferably life science) or nursing qualification.
- Experience of working in Pharmacovigilance or in a closely aligned field (eg Regulatory, Clinical, or Medical Information) within the pharmaceutical industry, medical or Regulatory environment
Skills
- Demonstrates a good understanding of the client organization, in particular the Global and International/Regional Safety groups and relevant local departments eg Regulatory and Clinical Teams. Knows where to go to for information and how the groups interact.
- Possess excellent interpersonal, verbal, and written communication skills. Able to research, compile and provide safety information in a clear concise manner to the local/regional team/Patient Safety HQ and externally. Sets consistent standards for others in local PV team to follow.
- Excellent understanding of local, regional and any other relevant legislation with regard to PV (eg ICH, CIOMS), as well as client corporate and local systems (eg Global Safety Database, local data bases) and procedures, in order to fulfil regulatory requirements for Pharmacovigilance.
- Maintains an awareness of the safety profile and any emerging pharmacovigilance/patient safety issues with client products (marketed or investigational) in the local affiliate and is able to represent the local Patient Safety function on cross-functional teams, providing input on drug safety issues. With support leads cross-functional teams for Risk Management and other safety related matters. Understands the importance of pharmacovigilance within the organization and increases recognition as a PV expert.
- Demonstrated ability to review safety information with attention to detail and accuracy, while managing multiple tasks & prioritizing work in order to meet strict deadlines. Utilizes effective problem-solving approaches to solve PV issues. Provides support to other PV Associates as required.
- Demonstrated ability to comply with relevant internal and external processes/guidelines/regulations.
- Strong ability to identify, address, resolve, and communicates safety issues and performs root cause analysis
- Minimal travel is required in this position.
Please send your CV to Naheed and call to discuss further.
We are an equal opportunities employment agency and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation, or age.
We champion differences in the world of technology recruitment and work with clients who actively wish to diversify their talent force - ALL applicants are welcome to apply.