|Location: High Wycombe, Buckinghamshire||Salary: £30 - £34 per hour|
|Type: Contract||Contact: Sam Davies|
Drug Safety Manager
Drug Safety Manager needed for a multinational Pharmaceutical Organisation based in High Wycombe who are looking to employ an experienced Drug Safety Manager with an in-depth knowledge of Pharmacovigilance and relevant compliance.
The successful Drug Safety Manager will want to work for this client not just because it's a great opportunity but also because they will receive an excellent pay rate: Up to £34.00 per hour.
What the role entails: Manage the Drug Safety team members including, the UK Drug Safety Scientist, UK Drug Safety Associate and UK Drug Safety Administrator to ensure that Drug Safety Reporting activities are carried out in compliance with Good Pharmacovigilance Practice Regulations. To deputise for the Senior Drug Safety Manager when required.
Some of the main duties of the Drug Safety Manager will include:
* Sign off memos in electronic system
* CAPA implementation, effectiveness review and trending
* Support coordination of internal and external audits and inspections
* Train staff and / or third-party partners with respect to pharmacovigilance
* Act as a key point of contact for studies or partner contracts
* Maintains oversight of aggregate reporting responsibilities, periodicity and submissions
* Contributes to global, regional and / or local projects
* Write, review, validate and implement local procedural documents and verify adherence
* Provide the office of the Qualified Person (QP) for pharmacovigilance any local information required to ensure compliance
* Support Country Safety Team Lead (CSTL) in responding to ad hoc requests as required
What you need to be the successful Drug Safety Manager:
In order to be the successful Drug Safety Manager and have a chance to gain such an exciting opportunity you will ideally need to have the following:
* Awareness of and familiarity with industry principles of drug development and pharmacology
* Proficiency in global and local SOPs
* Computer literate with expert knowledge of the Global Safety Database and/or expedited reporting module(s)
* Ability to prioritise and work to strict timelines on a daily basis
* Excellent verbal and written communication skills
* Ability to negotiate and communicate with internal and external customers
* Ability to work effectively as a member of the Drug Safety and broader Medical Department teams
* Ability to establish and maintain open relationships within the organisation and with authorities
* Knowledge and understanding of key legislation applicable to pharmacovigilance in the UK and Ireland.
* Proven expertise and experience in pharmaceutical regulations and R&D processes is desirable
* Degree-level qualification (ideally in life science) or equivalent nursing qualifications
This really is a fantastic opportunity for a Drug Safety Manager to progress their career. If you are interested please apply as soon as possible as this position will be filled quickly so don't miss out!
This advert was posted by Gold Group - one of the UK's leading niche recruitment consultancies. We span a variety of specialist industries and are the recruitment company to help you find your next career opportunity. We pride ourselves on our commitment to candidates and stick to our ethos of finding the right role for the right person. Visit our website or get in touch today to discuss this role, find out what else we've got or just for a chat about the state of your industry. Services advertised by Gold Group are those of an Agency and/or an Employment Business. Please be aware that we receive a high volume of applications for every role advertised and regularly receive applications from candidates who exceed the job credentials. We will only contact you within the next 14 days if you are selected for interview.