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Drug Safety/ Pharmacovigilance IT Business Analyst


Upper Gwynedd, PA
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Job Details

Job Title: Drug Safety/ Pharmacovigilance IT Business Analyst  - BUS002109

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 Global Safety Director responsible for IT Account Management for Global Drug Safety. 

The Business/Technical Analyst will be responsible for supporting the operational reporting needs for the Global Safety organization as well providing support on portfolio projects within the safety reporting, analytics, and signaling space.  

Major responsibilities include providing safety reports to our business colleagues for internal use and/or regulatory submissions, supporting health authority inspections/audits, business process analysis, analysis/investigation of potential design defects, requirements elicitation and documentation, UAT planning and coordination, requirements coverage through traceability to requirements, and leveraging of methodologies and tools, including Merck’s SDLC.

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

  • 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.
  • 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. 
  • Experience in creating and reviewing documentation specific to Merck’s SDLC. 
  • 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 
  • Ability to self-learn and develop business and technical knowledge quickly and apply these to the business problems
  • Experience with creating user stories, use cases, process flows, wireframes and data mappings
  • Ability to work independently and collaboratively
  • 5 years proven knowledge of business processes within the pharmaceutical space. 
  • Excellent written, communication, and presentation skills. 
  • 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
  • Familiarity with laws, rules and regulations applicable to the Global Safety industry

FLEX TIME, TELECOMMUTING available but MUST be in the Upper Gwynedd, PA office 1-3 days per week.

Our employees are the key to our company’s success.  We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.  Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.  If you need an accommodation for the application process please email us at
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:

Job Business/Technical Analysis

Primary Location NA-US-PA-Upper Gwynedd

Other Locations NA-US-NJ-Branchburg, NA-US-NJ-Rahway

Employee Status Regular

Number Of Openings 1

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