pharmalex_job_career

We are growing, grow with us!

Want to work in a dynamic company with daily new challenges and opportunities?  Then PharmaLex is your career opportunity!

PharmaLex is one of the leading service providers for the global pharmaceutical industry. We offer end-to-end regulated services and specialize in all aspects of approval and maintenance of medicinal products and medical devices. We support pharma companies throughout the entire product lifecycle, ensuring initial submissions and approvals as well as keeping compliance with pharmaceutical regulations worldwide. Our services extend way beyond market approval, providing high level strategic consultancy as well as hands-on work to extend product registrations into new markets across all regions of the world.

The success of our company grows with the excellent expertise and the high motivation of our employees.
 
If for you, your profession is not only a job but also a vocation and you enjoy working with people and in teams as part of a global organization, then you are very welcome to join us.
 
To strengthen our successful team, we are looking as of now (independent of location in Germany) for a:

(Senior) Specialist Pharmacovigilance -
Integrated Medical Information Services (m/f/d)

Your Job

Level 1 Medical Information
  • Receipt and management of Level 1 Medical Information enquiries via the PharmaLex Integrated Medical Information System, including triage for relevant area (pharmacovigilance and/or medical information and/or/product quality complaint).
  • Availability for incoming phone calls during the project-specific business hours
  • Regular monitoring of dedicated data entry channels (mailboxes etc.)
  • Responding to 1st Level MI enquiries according to approved reference documents
  • Escalating 2nd Level MI enquiries and other information to designated sites
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 inquiries)
  • Case processing (data entry), including translation German/English and quality check of translation
  • Data entry quality check (without case assessment)
  • Screening of local scientific literature (safety relevant publications), including creation of search algorithms for local literature screening
  • 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 literature surveillance and 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
  • Translation German/English in the context of case processing, including quality checks of translations
Quality systems
  • Tests computerized systems according to validation procedures
  • Perform quality control tasks such as project-specific quality checks
Program Management Support
  • Support the Program Manager with all necessary information related to the specific project/program, as needed
  • Project management
Your Profile
  • Degree in Life Science or equivalent with proven expertise and experience in GxP and / or pharmacovigilance (GVP) and related aspects
  • 0-2 years of experience in the field of pharmacovigilance, experience with receipt and management of safety-related information/product quality complaints/medical information I represents an advantage
  • Knowledge of relevant legislative and non-legislative guidelines on pharmacovigilance
  • Ability to organize operating procedures and to take over project management duties
  • Professional verbal and written communication skills with internal and external clients
  • Strategic, analytical and structured thinking
  • Flexibility and adaptability
  • Ability to adjust rapidly to new, unknown, challenging situations
  • Fluent in German and English
We offer you
  • Diverse and challenging job
  • Open and appreciative corporate culture
  • Flexible working hours based on trust
  • Possibility to work reduced number of hours
  • Possibility to work from home 
  • 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 receive your application documents stating your earliest possible starting date and salary expectations on-line.

Your contact person:

Alona Heiberger
HR Manager

www.pharmalex.com
PharmaLex GmbH
Bahnstrasse 42-46 ∙ 61381 Friedrichsdorf ∙ Germany
Tel.: +49 6172 76464322

 

Agencies only by prior agreement for the specific job opportunity.