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. You can be based from our Tring, Bourne End or Dublin office and/or work remotely.   


Associate Director,  Pharmacovigilance


Your Job

You will be the leader for the co-ordination of projects where PharmaLex assumes an extensive drug safety responsibility on behalf of the client for medicinal products/medical devices before,  during and after the marketing authorisation. 

As an Associate Director; reporting into the Director, Head of Pharmacovigilance UK & Ireland, you will be responsible for the implementation of operational tasks in the field of pharmacovigilance.  In this role, you will consult with clients at a high level as well as internal colleagues in a broad field of pharmacovigilance.  


Main tasks
  • You will be an expert for pharmacovigilance related questions within the department as well as for customers, national and international regulatory authorities
  • You will be responsible for the set-up, management, and participation in the operative part of pharmacovigilance systems
  • You will evaluate 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
  • You will prepare and review Clinical Expert Statements regarding requests from competent authorities
  • You will write/review procedural documents such as Working Instructions, SOPs, Working Procedures, Templates etc. for PharmaLex pharmacovigilance projects
  • You will Organize and perform training of the above-mentioned procedural documents
  • You will regularly monitor and evaluate changes in pharmacovigilance regulations
  • You will set-up and maintain PV agreements of clients with their contractual partners
In addition, you will be responsible for:
  • Training of staff in selected areas of pharmacology as well as training in safety-relevant aspects related to the use of medicinal products. In addition, contents in the field of development, production, examination and storage of medicinal products are provided
  • Follow-up of scientific and regulatory development especially concerning the topic pharmacovigilance and passing on relevant information to PharmaLex employees and clients
  • Education and training of pharmacists or pharmaceutical trainees as well as other health care professionals
  • QPPV/NCP
  • Program Manager


Your Profile

  • Degree in Natural Science or equivalent and ideally a higher degree
  • A minimum of 5 years pharmacovigilance work experience within PharmaLex or proven equivalent experience in global pharmacovigilance systems
  • Knowledge of relevant legislative and non-legislative guidelines of drug safety
  • Detailed knowledge of project-specific SOPs (internal and customer specific) as well as the global PharmaLex SOPs and pharmacovigilance department-relevant SOPs
  • Ability to organise operations and take over project management
  • Ability to analyse and solve problems and to develop pragmatic solutions within regulatory framework
  • Ability to balance client concerns and company interests
  • Ability to assimilate and analyse information rapidly
  • Ability to adjust rapidly to new, unknown, challenging situations
  • Autonomous, concentrated and high-quality work
  • Sense of responsibility
  • Fluent English language skills
  • Excellent oral and written communication skills


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.