Accountability for the execution of operational tasks in the field of pharmacovigilance
We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
We are looking for an experienced professional to join our team in Bourne End, who can provide maternity cover for the following role; the role will be for the period March 2020, until January 2021, with potential for the role to become permanent.
Manager, Pharmacovigilance (Maternity cover contract)
Leader for the coordination of projects where PharmaLex has been commissioned to take over comprehensive pharmacovigilance responsibility for a company’s medicinal product(s) in the pre-approval and post-approval phase.
Safety management remits
- Provide assistance to Qualified Person(s) for Pharmacovigilance (QPPV) and act as Deputy QPPV
- Evaluation of the benefit-risk profile of drugs based on current scientific knowledge - this includes the creation of safety update reports PSURs (Periodic Safety Update Reports) and associated documents such as AdCOs (Addendum to the Clinical Overview), DSURs (Development Safety Update Reports), RMPs (Risk Management Plans) and signal detection reports
- Creation and assessment of Individual Case Safety Reports (ICSRs) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and the literature; decision on expedited reporting; reporting of ICSRs to the competent authorities
- Identification of safety-related publications in the scientific literature; supporting the team members within the field of pharmaceutical scientific requests
- Preparation and review of Clinical Expert Statements
- Communication with regulatory authorities and client companies with regard to all pharmacovigilance-focused aspects
- Creation, review, update and implementation of Pharmacovigilance Agreements (PVAs)
- Preparation and maintenance of Pharmacovigilance System Master Files (PSMFs)
- Writing/Review of QA documents such as Working Instructions, SOPs, Working Procedures, Templates, Project Metafiles etc. for PharmaLex pharmacovigilance projects
- To organise and perform training of the above-mentioned QA documents
- Preparation of and participation in internal and external audits/inspections
- Guide clients through EV registration process. Act as a registered EV User of behalf of client companies
- Complete and submit XEVPRMs on behalf of clients
- Receive and handle medical information enquiries according to project processes
- Identification and appropriate processing of safety information received within medical information enquiries
- Knowledge in the field of pharmacology and medicine
- Knowledge of relevant legislative and non-legislative guidelines on pharmacovigilance
- Ability to organise operating procedures and to take over project management duties
- General knowledge of pertinent medical or pharmaceutical issues.
- Detailed knowledge regarding project-related SOPs (internal and client-specific), global PharmaLex SOPs and pharmacovigilance related SOPs
- Fluent English
- Professional verbal and written communication skills with internal and external clients
- Degree in Natural Science or equivalent and ideally also a doctorate degree
- Aim to regularly participate in internal and external professional training
- 5 Days holiday plus BH (increasing to 27 after qualifying service)2
- 8% employer pension contribution
- An opportunity to work within an organisation with a positive work/life balance environment
- Continuous development opportunities through knowledge and experience as well as training
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receiving your CV and a covering letter, explaining how you meet or exceed the specifications for this position, including your salary expectations on-line.
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Agencies only by prior agreement for the specific job opportunity.