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Job Details

PVG Reports and Submissions Manager

Company: Chiltern
Location: Cambridge
Reference: MLJ899080
Closing Date: 07 Dec 16
Type: Permanent
Salary (£): On Application
Benefits: Health Cash Plan, 25 days AL, Pension, LI, Income Protection

Job Summary:

Excellent opportunities have arisen to work in one of the most exciting areas of modern medicine within this innovative pharmaceutical company.

Requirements:

Founded in 1998 and is listed on both the NASDAQ Global Market and AIM, a market of the London Stock Exchange. They are licensed by the UK Home Office to work with a range of controlled drugs for medical research purposes.

Their vision is to make a positive difference in the lives of patients through the development of a portfolio of cannabinoid prescription medicines in a wide range of therapeutic indications.  Their strategy is to build on theri world leading position in the field of cannabinoid science and in the research, development and commercialization of cannabinoid molecules as novel prescription pharmaceutical therapeutic candidates.

Their  lead product is currently in Phase 3 FDA clinical trials being studied in a number of catastrophic childhood-onset epilepsy syndromes.  The product has been granted orphan drug status in those indications. They have assembled a large in-house team with extensive experience in developing cannabinoids, medicines containing controlled substances, as well as plant-based prescription pharmaceutical products. They maintain in-house control over all aspects of the cannabinoid product development process. They also hold GMP manufacturing licences for the manufacture of pharmaceutical products for both clinical trials and commercial purposes.

THE JOB

Responsible for the management of Pharmacovigilance reports and submissions for 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

Apply for this job: PVG Reports and Submissions Manager

Contact Information:

Address:  London, UK
171 Bath Road Slough Berkshire
SL1 4AA, UK
England
Tel:  +44 (0) 1753 512000
Fax:  +44 (0) 1753 511116
Website:  Visit Our Web Site

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