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 international team focusing on developing excellent solutions for the pharmaceutical industry.

Mission of the role


This position provides expert knowledge-based input to Sales, Marketing and Global Delivery (GD) teams in support of the company’s primary mission of expanding revenue and revenue opportunities, in line with overall company strategy.

Responsibilities:

Responsible for providing the company with in depth subject matter expert level knowledge of drug safety through three critical areas:

A.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.

B.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.

C.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.) knowledge of our copmany as setting 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.Prepares and delivers subject matter presentations, white papers, training, etc.

Requirements:
  • Advanced degree required (Master's or PhD or MD in mathematics, medicine, drug safety, medical information, epidemiology, (bio)statistics, outcome measurement, health services utilization highly preferred)
  • 10 years of drug safety or epidemiology experience. At least 6 years in pharmaceutical medical research with at least 3 of those years spent in product safety/pharmacovigilance/benefit-risk optimization.
  • Experience with suitable training in Epidemiology (e.g., an MPH, Biostatistics degree) or a related discipline is preferred.
  • Pharmaceutical industry experience preferred.
  • Experience working with large administrative or medical records databases required; prefer candidates with current statistical programming expertise.
  • Experience working with health authorities is preferred. The successful candidate will be expected to keep up to date with the FDA and other Regulatory Agencies regarding applications of electronic, patient-level databases and other emerging epidemiologic research tools.
  • Global experience preferred.
  • Authored in the subject preferred.
Skills:
  • Strong industry awareness (Life Science - pharmaceutical software)
  • Proven excellent interpersonal and communication skills
  • Effective time management & multi-tasking skills
  • Ability to analyze and relate customer issues/requirements
  • Proven ability to influence cross-functional teams effectively
  • Self-managed, self-starter, able to work in rapidly changing environment
  • High energy, detail oriented and creative individual
  • Ability to work both independently and cohesively in a team environment
  • Excellent communication skills both written and verbal required
  • Expertise in statistical software
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 international team focusing on developing excellent solutions for the pharmaceutical industry.

Mission of the role

This position provides expert knowledge-based input to Sales, Marketing and Global Delivery (GD) teams in support of the company’s primary mission of expanding revenue and revenue opportunities, in line with overall company strategy.

Responsibilities:

Responsible for providing the company with in depth subject matter expert level knowledge of drug safety through three critical areas:

A.    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.

B.    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.

C.    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.) knowledge of our copmany as setting 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.Prepares and delivers subject matter presentations, white papers, training, etc.

Requirements:

  • Advanced degree required (Master's or PhD or MD in mathematics, medicine, drug safety, medical information, epidemiology, (bio)statistics, outcome measurement, health services utilization highly preferred)
  • 10 years of drug safety or epidemiology experience.   At least 6 years in pharmaceutical medical research with at least 3 of those years spent in product safety/pharmacovigilance/benefit-risk optimization.
  • Experience with suitable training in Epidemiology (e.g., an MPH, Biostatistics degree) or a related discipline is preferred.
  • Pharmaceutical industry experience preferred.
  • Experience working with large administrative or medical records databases required; prefer candidates with current statistical programming expertise. 
  • Experience working with health authorities is preferred. The successful candidate will be expected to keep up to date with the FDA and other Regulatory Agencies regarding applications of electronic, patient-level databases and other emerging epidemiologic research tools. 
  • Global experience preferred.
  • Authored in the subject preferred.

Skills:

  • Strong industry awareness (Life Science – pharmaceutical software)
  • Proven excellent interpersonal and communication skills
  • Effective time management & multi-tasking skills
  • Ability to analyze and relate customer issues/requirements 
  • Proven ability to influence cross-functional teams effectively
  • Self-managed, self-starter, able to work in rapidly changing environment
  • High energy, detail oriented and creative individual
  • Ability to work both independently and cohesively in a team environment
  • Excellent communication skills both written and verbal required
  • Expertise in statistical software

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