Job Description

The Position

The Organon Business Technology Services (BTS) Pharmacovigilance Safety Systems Business Technical Analyst will be responsible for providing support and business/technical analysis efforts for the Organon Pharmacovigilance Safety Systems platforms, including requirements gathering, support, delivery, enhancement and vendor management.

This individual should have a familiarity with core Pharmacovigilance processes as well as BTS core processes such as change management, service management, SDLC, and incident management. This individual should understand analytics/AI relating to supporting and driving efficiencies in processes. This individual should have strong collaboration and communication skills to work with business clients, our service management team, and our vendor(s) to provide best possible responses and services to our business clients.

The individual should have experience with Compliance, Computer Systems Validation, and Data Integrity and how these are implemented day-to-day in the work BT does to deliver and support BT platforms for the business. This individual will work closely with the Pharmacovigilance Safety Systems Platform Lead and the Agile delivery teams in the overall management, delivery, and support of our Pharmacovigilance Safety platforms.

The primary responsibilities of this individual will be to assist the platform lead in managing the following aspects of our Pharmacovigilance Safety Systems:

• New capability / module delivery
• Support for Operational delivery teams
• Analytics/AI/Automation opportunities
• Partnering with other team members for requirements definition and new solution builds
• Business communication / governance

As a member of the Pharmacovigilance Safety BTS team for Organon, this individual will work closely with the business and other members within BTS to ensure that the Pharmacovigilance Safety platforms are maintained and providing the required capability to the business. This includes facilitating the proper uptime, managing upgrades/releases, managing support, partnering with the vendor, and working with the other team BTS leads to support build and deliver new capabilities within the systems. Experience with GxP processes preferred (Deviations, Document Management, CAPAs, Change Control). Agile delivery experience and understanding is also preferred.

The individual should be proactive, personable, adaptable and a good communicator. The responsibilities include stakeholder management, project management, solution management, business / vendor management, and supporting and troubleshooting production issues, running daily management calls.

This individual will be part of the global Pharmacovigilance Safety team and will support all business functions globally.

Responsibilities

Primary activities/responsibilities

• Partner with other teams to ensure top tier support to business clients for Pharmacovigilance Safety systems.
• Partner with other team members to manage the Pharmacovigilance Safety platforms day to day – including delivery and support
• Establish and review metrics for support and overall platform operations
• Work alongside developers and testers, as well as collaborate with Internal and External vendor teams
• Support effective business analysis through analytical thinking, problem-solving and communication skills
• Work closely with members of our delivery team, including stakeholders, development and Quality & compliance teams to implement new solutions and updates to our current Pharmacovigilance Safety solutions
• Understand SDLC and within this framework for system deliverables to ensure flawless validation execution.
• Establish strong business understanding and relationships with Pharmacovigilance Safety business partners.
• Work with team to identify ongoing opportunities for improvement

Required Education, Experience, and Skills
Qualifications:

• Bachelor’s degree or equivalent in Information Technology, Science, or Business-related field
• At least 2 years relevant experience in business analysis, working with business teams, building & delivering effective business processes aligned to solutions, providing IT support.
• Strong Business analysis skills, including documenting business and technical requirements.
• Knowledge of core Pharmacovigilance Safety business processes
• Familiarity / experience with Agile solution delivery (SAFe) is a plus.
• Knowledge/experience of development and deployment of foundational & innovative solutions in any business domain from conceptualization through delivery.
• Strong working knowledge of SDLC requirements
• Strong knowledge of Data Integrity industry requirements and how they apply to IT
• Team collaboration experience and skills
• Strategic thinking
• Ability to thinking cross-divisionally and working across boundaries
• Project management, influencing & organizational skills
• Relationship management and networking: strong integration into the IT network and ability to build productive relationships with all parties
• Excellent interpersonal , facilitation and communication skills

• Experience in Pharmacovigilance Safety Systems and associated Pharmacovigilance Safety business processes preferred

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

10%

Flexible Work Arrangements:

Flex Time, Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R534378