Description
Qualifications
Biomedical degree (or equivalent), or above.
Background in drug safety (signal evaluation/aggregate reporting) or other relevant field (e.g. clinical development, medical writing, medical information) preferred.
Role Description
To assist in the continued safety assessment, evaluation and risk management of products in Global Clinical Safety & Pharmacovigilance (GCSP) department in the Safety Evaluation & Risk Management (SERM), Mature Products group. This group is responsible for supporting company's portfolio of established products - both innovator products (Pharma and Consumer Health) and generics. This role will be focused on Pharma and/or Consumer Health products. This is a safety evaluation/risk management/aggregate report writing role rather than processing of individual adverse event reports.
Exact duties will depend on your level of experience, but may include the following:
* Proactive monitoring and evaluation of all aspects of the safety profile of designated products.
* Preparing safety documents (e.g. periodic reports, labelling documents, regulatory enquiries, risk management plans) accurately and in a timely manner to meet global compliance and regulatory requirements.
* Support the discussion and management of safety issues through matrix teams across the global organisation.To be successful you will be able to demonstrate the following:
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* Highly analytical thinking, with the ability to analyse clinical safety and scientific data, whilst applying sound judgment.
* Effective written and verbal communication skills.
* The ability to function independently as well as part of a team.
* Good decision making and problem resolution based on all relevant information.
* Attention to detail and the ability to work effectively in an environment characterised by tight timelines and changing priorities.
* The ability to apply pharmacovigilance expertise to a range of products across the portfolio as the need arises.
* Self-motivated, with the intellectual flexibility to learn new skills.
An awareness of international pharmacovigilance requirements, e.g. ICH, EU pharmacovigilance regulations, and CIOMS initiatives.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.
