Senior Specialist, BT Pharmacovigilance

This job is with Organon, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Job Description

The Position

The Senior Specialist, BT Pharmacovigilance will report directly to the Director of Pharmacovigilance Business Technology and will be a key member of the R&D Business Technology Services team.

This individual is responsible for providing support and business / technical analysis efforts for the Pharmacovigilance systems, including requirements gathering, support, delivery, enhancement and vendor management.  This individual should have a familiarity with core Pharmacovigilance drug Safety processes as well as BTS core processes such as change management, service management, SDLC, and incident management.  This individual should have strong collaboration and communication skills to work with business clients, our service management team, and our vendors to provide the best possible responses and services to our business clients.

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

Responsibilities

Ensure top tier support to business clients for Global Safety systems.

Manage the Global Safety platforms day to day - including delivery and support

Establish and review metrics for support and overall platform operations

Serve as a functional owner for the PV Reporting system (PV Reports), Case Management (Argus Safety) and related systems.

Meet all compliance obligations through tasks such as requirements elicitation and documentation, User Acceptance Test planning and coordination, requirements traceability, and software development lifecycle (SDLC) best practices.

Work directly and collaboratively with business and technology stakeholders across disciplines and at all levels to implement new solutions and updates to our current Global Safety systems

Required Education, Experience, and Skills

Bachelor's degree or equivalent in Engineering, Sciences, Information Systems, or related field preferred.

At least 8 to 10 years of relevant experience in business analysis, working with business teams, building and delivering effective business processes aligned to Pharmacovigilance Drug Safety solutions

Providing IT support for Pharmacovigilance Global Safety Applications like PV Reports, Argus Safety, PV Signals.

Demonstrated ability to succeed in a complex and dynamic work environment.   Proven ability to manage multiple priorities and tasks simultaneously.

Strong commitment to tangible and valuable outcomes.

Experience creating user stories / requirements, use cases, process flows, wireframes and data mappings encompassing facilitation, negotiation, and trade-off analysis.

Ability to adapt and rapidly learn new technologies and apply their findings to solve key business challenges.

Strong analytical and problem-solving skills balanced with a creative mindset.

Strong interpersonal skills including teamwork, facilitation, and the ability to influence.

Experience in creating and reviewing IT Software Development LifeCycle (SDLC) documentation.

Preferred Experience, and Skills

Agile development experience preferred.

Domain knowledge of Pharmacovigilance and Drug Safety

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 :

Hybrid Shift :

Valid Driving License :

Hazardous Material(s) :

Number of Openings :

Requisition ID : R536929

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