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Drug Safety/Pharmacovigilance IT Analyst

Gwynedd, PA

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Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its 
legacy for over a century
. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

This position reports directly to the IT Client Services Director responsible for Global Clinical Safety & Pharmacovigilance IT strategy and value realization for Merck. This position will be aligned to the portfolio of projects and assigned to initiatives in support of the client area of Global Drug Safety, ranging anywhere from case intake, case processing/management, to reporting and analytics. The incumbent may also be responsible for supporting operational reporting needs for the global safety organization.

The Business/Technical Analyst must be able to work directly with and effectively communicate with business colleagues as well as be able to bridge the gap between the business and technical teams. This position requires a proactive individual who can take initiative to drive and lead business requirement discussions, as well as identify and resolve any defects/issues in design or requirements.

Under the leadership of the IT Global Safety Director, the individual will understand business processes and operating environment and lead project based activities including business process analysis, scope definition / chartering, requirements elicitation and documentation, UAT planning and coordination, requirements coverage through traceability to requirements, leveraging SDLC methodologies and tools. The individual will also interface directly with the designated business area(s) to document current and future state business process and information flow maps.

The individual must be able to work independently and creatively. The incumbent should expect to work collaboratively both locally and globally with business partners, Merck Research Labs IT colleagues, internal Merck IT shared services colleagues, and third party solution providers/suppliers, consultants, and contractors.

TELECOMMUTING available but MUST be in the Upper Gwynedd, PA office 2-3 days per week
Education Minimum Requirement:
Bachelor's Degree, with concentration in Engineering, Sciences, Information Systems or related field preferred. Degree in health sciences with technical experience will also be considered.
Required Experience and Skills:
A minimum of 5 years of IT business/technical analysis experience or 3 years experience working within the drug safety/pharmacovigilance domain
Strong interpersonal skills including teamwork, facilitation, communication and the ability to influence. 
Strong analytical and problem-solving skills balanced with a creative mindset
Strong knowledge of business analysis, best practices and methodologies including the ability to perform requirements tracing and validations during testing
Demonstrated requirements gathering skills through development of use cases and other methods and skills used in business analysis such as negotiation, decision making / trade off analysis, and problem solving skills 
Demonstrated success in building strong relationships with client organizations and across other IT areas 
Demonstrated ability to succeed in a complex and dynamic work environment. 
Process mapping experience 
Experience with creating user stories, use cases, process flows, wire frames and data mappings
Ability to work independently and collaboratively
Strong interpersonal skills including teamwork, facilitation, communication and the ability to influence. 
Experience in creating and reviewing documentation specific to Merck’s SDLC, specifically with health authority regulated systems. 
Change Management experience
Demonstrated skills in developing compelling business cases and solution recommendations; specifically ensuring high quality materials to facilitate client conversations and presentations 
Demonstrated ability as a self-starter with ability to effectively manage several complex projects across multiple business areas at the same time
Excellent verbal and written communication and presentation skills
Experience working in a cross-functional, global team consisting of internal employees as well as third party solution providers, consultants and contractors.
Preferred Experience and Skills:
5 years proven knowledge of business processes within the pharmaceutical space. 
Ability to understand, align and ensure integration of IT business and solution architecture with business solutions.
Experience working with partners/suppliers, consultants and/or contractors.
Agile/scrum experience
Experience with PL/SQL and relational databases
Experience with Argus Safety, Spotfire, Empirica, Cognos, PV Reports, ArisG
Familiarity with laws, rules and regulations applicable to the Global Safety industry
Experience with formal hardware, software, or services selection process and working with procurement (request for proposal process)
Experience with financial planning
Familiarity with laws, rules and regulations applicable to the Global Pharmacovigilance/Safety industry is desirable
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to
Search Firm Representatives Please Read Carefully: 
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit:
            EEOC Poster
            EEOC GINA Supplement
Business/Technical Analysis
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Yes, 10 % of the Time
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