Merck Drug Safety/Pharmacovigilance, IT Assoc. Director in Upper Gwynedd, Pennsylvania

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.

This is a Sr. Business Analyst position that 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 primarily in support of the client area of Global Drug Safety. This role will specifically have BA responsibilities over the global adverse event intake and individual case management space, along with some cross-functional responsibilities within the adverse event reporting and analytics space.

Under the leadership of the IT Global Safety Director, the individual will understand business processes and operating environment and will be responsible to ensure the alignment and integration of IT solutions in support of business strategies across Global Safety ensuring realization of the desired end state in support of the portfolio. Key responsibilities include but are not limited to driving business case development, leading global, cross-functional innovation initiatives, leading 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 methodologies and tools, including Merck’s SDLC. This role also requires driving of financial/portfolio planning and contracting discussions with procurement vendors as necessary.

The individual will also interface directly with technical team members to effectively translate business requirements and capability needs, as well as with the designated business area (s) to document current and future state business and process and information flow maps.

This is a client-facing role which has a high level of interaction with our business partners at all levels and as such, a strong customer service mindset with the ability to guide and think strategically with our business partners is imperative. The individual should possess the ability to understand immediate and long term business needs and have the ability to formulate and translate into an effective strategy. The individual should also be able to introduce best practices and process improvements ideas where appropriate, and have experience mentoring and/or managing individuals and teams.

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 8 years of IT business analysis experience, or equivalent experience working within the drug safety/pharmacovigilance technology space.

  • 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, specifically with health authority regulated systems.

  • 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

  • Change Management experience

  • Proven experience with creating user stories, use cases, process flows, wire frames and data mappings

  • Must be able to develop and articulate a plan of action, whether in support of strategy development or planning a road map. This plan must be clear, compelling and understandable, and flow in a logical fashion with supporting rationale as appropriate.

  • 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.


  • 8 years proven knowledge of business processes within the pharmaceutical space.

  • Experience working with innovative experiments, specifically contributing to idea generation, idea incubation, and/or experimentation; and identifying tangible and measurable criteria

  • Proven leadership and people management skills are preferred, along with excellent written, communication, and presentation skills.

  • Ability to understand, align and ensure integration of IT business and solution architecture with business solutions.

  • Experience managing partners/suppliers, consultants and/or contractors.

  • Agile/scrum experience

  • Experience with Argus Safety, Spotfire, Empirica, Cognos, PL/SQL, SQL, PV Reports, ArisG

  • 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

  • Experience with practical of innovative technologies such as machine learning, natural language processing, robotic process automation, cognitive computing, etc.

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 .

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Visa sponsorship is not available for this position.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job Business/Technical Analysis

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Title: Drug Safety/Pharmacovigilance, IT Assoc. Director

Primary Location: NA-US-PA-Upper Gwynedd

Requisition ID: BUS002839