Senior Specialist, Pharmacovigilance

3 days ago

Bourne End, United Kingdom Pharmalex Full time

**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.

**Senior Specialist, Pharmacovigilance**

**Your Job**

You will be accountable for the execution of operational tasks in the field of pharmacovigilance that require specific technical expertise in the field of medicines and medical documentation.

This is an exciting new role that has been created as a result of continuing growth in this area of the business. It's a great opportunity to join a friendly team and experience a wide range of pharmacovigilance activities in a consultancy environment. This position can be based from our Tring or Bourne End office and/or work remotely. If you have at least 3 years pharmacovigilance or drug safety experience and you're ready for your next challenge, take a look at this role. We look forward to hearing from you

**Main tasks**

**Case Management and Local Literature Screening**
- Management of safety-relevant information (level 1) from all sources (including, but not limited to spontaneous, literature, clinical studies, medical information enquiries)
- Case processing (data entry)
- Data entry quality check (without case assessment).
- Screening of local scientific literature (safety relevant publications), including creation of search algorithms for local literature screening
- Performing administrative and operative tasks within Vigilit® (literature surveillance tool) such as management of contract and user accounts, upload references and reporting documents into the Vigilit® web system
- Tracking of the internal literature ordering process
- Support with creation of Individual Case Safety Reports (ICSR) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and from the literature; reporting of ICSRs to the competent authorities
- Documentation of case processing on a company and a case level
- Support in the generation, processing and tracking of follow-up requests
- Handling of Customer enquiries or complaints in the scope of VigiLit (literature surveillance) and VigiCare (case processing) according to quality assurance requirements
- Assistance in the creation of periodic reports PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), risk management plans and signal detection reports
- Assist Manager Pharmacovigilance in managing clinical trials
- Contact with clients (e.g. meetings, client visits, etc.)

**Quality Systems**
- Test computerized systems according to validation procedures
- Author/review procedural documents such as Working Instructions, SOPs, Working Procedures, templates etc. for PharmaLex pharmacovigilance projects
- Organize and perform training of the above mentioned procedural documents
- Perform quality control tasks such as project-specific quality checks
- Preparation of and participation in internal and external PV audits/inspections
- Ensure management of Corrective and Preventive Actions (CAPA) for own processes, including tracking of CAPA status.
- Perform Regulatory/PV Intelligence screens of the applicable sources (e.g. Authority websites) and alignment with (Senior) Manager PV on gap analysis/impact assessment.

**Program Management Support**
- Support the Program Manager with all necessary information related to the specific project/program, as needed.
- Project management.

**QPPV/PSMF support**
- Support the QPPV/GPO with all necessary information related to the specific project/program, including extraction and compilation of applicable data and information for the PSMF.

**Other**
Support for PVA management: data entry and maintenance of Client / PVA information in VigiContract®
**Your Profile**
- Medical Documentation specialist or University degree in Life Science
- Degree in Life Science or equivalent with proven expertise and experience in GxP and / or pharmacovigilance (GVP) and related aspects
- 3-5 years of experience in the field of pharmacovigilance
- Excellent knowledge of relevant legislative and non-legislative guidelines on pharmacovigilance
- Detailed knowledge regarding project-related SOPs (internal and client-specific), global PharmaLex SOPs and pharmacovigilance related SOPs
- Ability to organize operating procedures and to take over project management duties
- Professional verbal and written communication skills with internal and external clients
- Fluent in English
- Excellent written and verbal communication skills
- Self-confident and assertive
- Confidence to work alone as well as in a team
- Strategic, analytical and structured thinking
- Ability to assimilate and analyse information rapidly
- Flexible and adaptable with the ability to adjust

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