Reports and Submissions Manager - Pharmacovigilance

Reports and Submissions Manager - Pharmacovigilance

Cambridge, UK

The Role

Responsible for the management of Pharmacovigilance reports and submissions for GW's human medicinal products in both the pre- & post-marketing setting the role holder will be a dedicated manager who will actively run the reporting system in the department, with a focus on maintaining compliant and current core safety documents, plan all updates and carry out all submissions within the legal timelines.  The post holder will lead the communication of safety information into other operational functions.

Key Responsibilities

• Support the QPPV, escalating safety and non-compliance issues
• Actively maintain product core safety information 
• Actively manage the safety report scheduling, resources and timelines.
• Track and maintain compliance with regulatory timelines and submission requirements.
• Work closely with the safety surveillance and case processing teams to achieve submission timelines
• Manages new safety information resulting in updates to the core safety documents in a timely manner.
• Organising and scheduling cross-functional meetings to communicate core safety changes.
• Line management
• Database searches and running reports
• Responsible for organizing and tracking safety information requests and responses
• Maintaining a strong GPVP & GCP knowledge.
• The job holder is responsible for maintaining cGxP and H&S knowledge applicable to the job

Essential Skills & Experience

Knowledge:

• Full understanding of clinical trials and the drug development process.
• Life sciences degree with a sound clinical knowledge in diverse therapeutic areas
• Strong background in drug safety / pharmacovigilance and document management
• Thorough knowledge of safety regulations and legal requirements
• Extensive pharmaceutical safety experience.
• Experience of case management and safety report submissions, metrics.

Skills:

• An experienced manager
• Proficiency in safety databases, producing submissions metrics and medical coding
• Excellent communication skills including the ability to work with people at all levels.
• Excellent organisational and time management skills.
• Ability to be proactive, work on own initiative as well as part of a team.
• Good attention to detail.

Attributes and Behaviours:

• Have the ability of prioritising, planning and organising workload.
• Maintain a positive working environment within the office
• Demonstrate a “can do” approach.
• Demonstrate highest level of confidentiality and discretion
• Willingness to travel if required.

Desirable Skills & Experience

• Management in a drug safety/Pharmacovigilance environment.

Location: Cambridge, UK

To apply, please send your C.V, cover letter and salary expectations to recruitment@gwpharm.com by clicking apply.