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 Pharmacovigilance, you can be based from any of our UK offices.
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. To work closely and provide support to the EU QPPV and build positive working relationships with clients and colleagues.
Safety management remits
- Build and maintain strong working relationships with clients
- Provide PV advice to project stakeholders when requested
- Prepare, review and approve, as required by client:-
- Safety Management Plans (SMPs)
- Safety Data Exchange Agreements (SDEAs) between MAHs and commercial partners/service providers
- Periodic Safety Update Reports (PSURs)/Development Safety Update Reports (DSURs)/PADERs within agreed regulatory timelines;
- Pharmacovigilance System Master Files (PSMFs) for MAHs in the EU;
- Maintain eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD);
- Perform case processing for Marketed Product ADRs and Clinical Trial SAEs to include coordination of medical review as required;
- Perform timely submission of Individual Case Safety Reports (ICSRs) to relevant Competent Authorities (CAs) and ECs;
- Regularly review literature to identify relevant safety information;
- Coordinate and facilitate signal management and the continuous risk-benefit evaluation of relevant products by monthly report;
- Prepare, attend, contribute to and chair routine client safety review meetings;
- Identify emerging safety concerns to the EU QPPV and MAHs;
- Co-ordinate GVP audits of MAH PV systems as required;
- Prepare and maintain the Company Core Safety Information (CCSI) for Client products if required
- Write and/or review (in conjunction with the study sponsor) safety sections of study reports.
- 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
- 25 Days holiday plus BH (increasing to 27 after qualifying service)
- 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.
To apply, please don't hesitate to contact us
Manager, Human Resources UK/Ireland
Agencies only by prior agreement for the specific job opportunity.