Country: Germany
Functional area: Pharmacovigilance
On behalf of our multinational software provider client we’re currently looking for an experienced pharmacovigilance expert who would be an essential addition to a vibrant internation team focusing on developing excellent solutions for the pharmaceutical industry.

Mission of the role

The primary functionof this subject matter expertposition is to bring customer facing, inward facing and Industry / agency thought leadership experience to out client’s drug safety software offerings.

Tasks & Responsibilities

Customer facing:During discussions with potential customers, bring to bear extensive knowledge of the field, and explain not only how our products would suit them, but what they should be doing relating to drug safety, etc. Assist clients in overcoming the resistance in the industry to certain techniques, partly cultural and partly regulatory in origin and assist them in navigating through their concerns is an essential component.

Inward facing:Internally, this position will provide direction to help develop and design software tools so that they function appropriately. Working with different individuals involved, assist in the ongoing projects related to the Safety suite as well as the creation of new offerings in the area of risk management. The SME will be responsible for solidifying and extending these capabilities, including the definition of new capabilities to help support drug safety committees in their decision making. The SME will be responsible for identifying and maintaining relationships with development partners and monitor the development process of these strategic extensions.

Industry / agency thought leadership: This position will liaise with agencies on behalf of customers who might be particularly reserved about certain issues, and it is useful to be able to make thoughtful experienced arguments. At the same time, we would like to establish in industry forums (through speaking, writing, etc.) in oder to set the standard for how drug safety and pharmacovigilance should be conducted in terms of industry best practice. The best practices in many cases don’t actually exist, but customers are eager for knowledge about ‘how others do it right’. We can convey that and help to establish the best practice where it does not yet exist.

Requirements: education/Experience
  • Advanced degree required
  • 10 years of Risk Management or epidemiology/post-marketing safety signal detection and management/Aggregate Reporting experience.
  • Excellent English language knowledge
  • Pharmaceutical industry experience preferred.
  • Experience on development and implementation of risk management strategies including but not limited to EMA RMP, FDA REMS, GVP, Labeling updates and Safety communications.
  • Experience working with novel signal detection methods (Disproportionality, Bayesian and Logistic regression) in drug safety domain
  • ability to travel internationally up to 30% of the work time
Should you be interested in the role please apply by sending your CV/should you have any question in regards the vacancy do not hesitate to leave a comment with your details.
On behalf of our multinational software provider client we’re currently looking for an experienced pharmacovigilance expert who would be an essential addition to a vibrant internation team focusing on developing excellent solutions for the pharmaceutical industry.

Mission of the role

The primary function of this subject matter expert position is to bring customer facing, inward facing and Industry / agency thought leadership experience to out client’s drug safety software offerings.

Tasks & Responsibilities

Customer facing: During discussions with potential customers, bring to bear extensive knowledge of the field, and explain not only how our products would suit them, but what they should be doing relating to drug safety, etc. Assist clients in overcoming the resistance in the industry to certain techniques, partly cultural and partly regulatory in origin and assist them in navigating through their concerns is an essential component.

Inward facing: Internally, this position will provide direction to help develop and design software tools so that they function appropriately. Working with different individuals involved, assist in the ongoing projects related to the Safety suite as well as the creation of new offerings in the area of risk management. The SME will be responsible for solidifying and extending these capabilities, including the definition of new capabilities to help support drug safety committees in their decision making. The SME will be responsible for identifying and maintaining relationships with development partners and monitor the development process of these strategic extensions.

Industry / agency thought leadership: This position will liaise with agencies on behalf of customers who might be particularly reserved about certain issues, and it is useful to be able to make thoughtful experienced arguments. At the same time, we would like to establish in industry forums (through speaking, writing, etc.) in oder to set the standard for how drug safety and pharmacovigilance should be conducted in terms of industry best practice. The best practices in many cases don’t actually exist, but customers are eager for knowledge about ‘how others do it right’. We can convey that and help to establish the best practice where it does not yet exist.

Requirements: education/Experience

  • Advanced degree required
  • 10 years of Risk Management or epidemiology/post-marketing safety signal detection and management/Aggregate Reporting experience.
  • Excellent English language knowledge
  • Pharmaceutical industry experience preferred.
  • Experience on development and implementation of risk management strategies including but not limited to EMA RMP, FDA REMS, GVP, Labeling updates and Safety communications.
  • Experience working with novel signal detection methods (Disproportionality, Bayesian and Logistic regression) in drug safety domain
  • ability to travel internationally up to 30% of the work time

Should you be interested in the role please apply by sending your CV/should you have any question in regards the vacancy do not hesitate to leave a comment with your details.English home based