pharmalex_job_career


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 Pharmacovigilance team.  We are keen to receive applications from candidates looking for full-time or part-time employment and job share would also be considered. You can be based from our Tring or Bourne End office and/or work remotely.   


Senior Manager,  Pharmacovigilance (F/T or P/T)


Your Job

Leader for the co-ordination 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. 

As a Senior Manager; reporting into the Director, Head of Pharmacovigilance UK & Ireland, you will have accountability for ensuring that efficient and compliant processes are in place to allow timely collection and reporting of patient safety data. This role will act as a main client contact and liaison with internal departments and external business partners on pharmacovigilance (PV) operational issues and related activities, such as: represent Drug Safety/PV on study management teams, oversee case processing activities, draft/review safety/clinical related documents as required.

Line management responsibility for two employees.


Safety management remits
  • Assume the role of Qualified Person(s) for Pharmacovigilance (QPPV) or deputy for UK authorised products
  • Assume the role of Local Responsible Person for Pharmacovigilance and/or UK National Contact Person
  • Project management of multi-country local pharmacovigilance services
  • Advising clients on MHRA PV requirements  
  • 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), risk management plans and signal detection reports.
  • Overseeing and supporting:
    • Individual Case Safety Report (ICSR) assessment 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
    • Preparation and review of Clinical Expert Statements
    • Preparation and maintenance of Pharmacovigilance System Master Files (PSMFs)
  • Communication with regulatory authorities and client companies with regard to all pharmacovigilance-focused aspects
  • Creation, review, update and implementation of Pharmacovigilance Agreements (PVAs)
  • 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 on behalf of client companies
  • Complete and submit XEVPRMs on behalf of clients
  • Mentoring colleagues in the above tasks
Medical Information remits
  • Writing/Review of QA documents such as Working Instructions, SOPs, Working Procedures, Templates, Project Metafiles etc. for PharmaLex medical information projects
  • Overseeing and supporting:
    • Receipt and handling of medical information enquiries according to project processes
    • Identification and appropriate processing of safety information received within medical information enquiries
    • Mentoring colleagues in the above tasks


Your Profile

  • Degree in Natural Science or equivalent and ideally a higher degree
  • 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
  • Demonstrated commercial and business awareness
  • Fluent English
  • Professional verbal and written communication skills with internal and external clients
  • Aim to regularly participate in internal and external professional training


We offer

  • Competitive salary and benefits package
  • 25 days holiday plus bank holidays (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

Helen Pietropaolo
Manager, Human Resources UK/Ireland


 

Agencies only by prior agreement for the specific job opportunity.