SUBJECT MATTER EXPERT (SME) – SAFETY

JOB TITLE:  SUBJECT MATTER EXPERT (SME) – SAFETY
REPORTS TO:  PRESIDENT
LOCATION: US – CONNECTICUT, NEW JERSEY, PENNSYLVANIA

GENERAL SUMMARY
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.
The primary function of this subject matter expert position is to bring customer facing, inward facing and Industry / agency thought leadership experience to Aris Global’s drug safety offerings.  This position requires in-depth experience in drug safety, particularly as it can be practically applied.  A person that is practically and professionally involved both in the industry and academically would bring extra credibility to the position.

The subject matter expert (SME) will support the company’s primary goal of expanding revenue and revenue opportunities by amplifying Sales and Marketing departments’ capabilities to address topics of special expertise, current events and industry trends.
The SME will support the company’s ability to address the market domains, by ensuring that industry needs and trends are documented and communicated to GD, and that GD are equipped with the relevant knowledge in order to develop and implement the Aris Global product range in a way that can be maximally exploited.  During this process the SME will continue to work with identified industry partners and will continue to monitor and provide input into the GD development process of the product.
The SME will also be responsible for presenting the tought leadership towards the industry through active participation in industry events.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Responsible for providing Aris Global 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 creation of drug safety elements. The SME will be responsible for solidifying and extending these capabilities, including the definition of new capabilities to help support drug safety committees and the like 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 Aris Global 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.

Accomplishes financial objectives by forecasting financial requirements; preparing an annual budget; scheduling expenditures;analyzing variances; initiating corrective actions.
Prepares and delivers subject matter presentations, white papers, training, etc.


REQUIREMENTS:  EDUCATION/EXPERIENCE
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 and 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
required.
Pharmaceutical industry experience preferred.
A sophisticated understanding of, and the ability to interpret quantitative methods is required. Experience and
understanding with writing statistical methods sections of study proposals and/or proposal requests or background epidemiologic material on specific diseases, conditions, or therapies 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 to Aris Global solutions. 
• 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.

WORKING CONDITIONS
Normal office environment. Ability to work under stress and tight deadlines. Ability to travel up to 50%of the time as needed.

HOURS
Standard Hours 40 hours per week, one hour lunch, Monday – Friday.   Additional hours as needed.

send your resume to careers@arisglobal.co.in

Aris Global is an Equal Opportunity Employer/ Committed to Diversity