Job Description
The Position
Serves as the primary point of contact for PV agreements associated with Vendors (eg: third party suppliers), as applicable, and Business Partners. Ensure standards are consistent with Company policies and Health Authority regulations. Provide mentorship and guidance to local PV Responsible Leads associated with their local vendor PV agreements. Subject Matter Expert (SME) for audits, inspections, quality related incidences, and Company related initiatives.
Responsibilities:
Incorporate appropriate safety reporting language in agreements with Vendors and Business Partners, such as Master Service Agreements (MSA), Statement of Work (SOW), Purchase Orders (PO), Distribution and Promotion Agreements, In-licensing Agreements, Contribution Agreements or Other Business Partner related agreements requiring PV Agreement and/or PV language.
Performs PV Due Diligence for U.S. and Global contracts with external vendors to ensure PV compliance and adherence to Corporate Policy standards.
Provide support to PV Agreement and Alliance Management Team regarding Business Partner responsibilities per Company Standard Operating Procedures.
Participates in inspection readiness activities and preparation as needed. This includes the support for the Pharmacovigilance System Master File (PSMF).
Reviews and provides appropriate PV language in US and global vendor agreements (eg: Master Service Agreements or standalone PV agreements) which programs have potential reporting of adverse events and product quality complaints.
Performs PV due diligence reviews with vendors.
Mentor and provide guidance to PV affiliates related to vendor PV agreements.
Collaborates with Procurement and Business Project Owners to ensure the appropriate PV agreement classifications and requirements are embedded in the agreements.
Provides support for quality related initiatives associated with PV agreements.
Required Education, Experience, and Skills:
Bachelor's degree or master's degree in a life science/health care/pharmaceutical related field
Minimum of 3 years of experience in the pharmaceutical industry with a specific focus on pharmacovigilance related activities.
Experience collaborating with Vendors and Business Partners.
Experience with Procurement related engagements with third party suppliers and processes.
Demonstrated ability to build and manage close relationships with key stakeholders within the region.
Understands the differences between a Vendor and a Business Partner.
Highly proficient with PV agreements associated with providing services on behalf of the Company, such as commercial and marketing programs, Company owned studies, and PV related services.
Highly proficient with PV agreements associated with Business Partners which provides clear guidance on accountability and responsibility between both parties.
Knowledge of PV principles, systems, and requirements in addition to PV regulations.
Strong analytical skills, quality focus, and detail oriented.
Problem solving, conflict resolution, critical thinking skills, and project management.
Ability to function with a high degree of autonomy, quickly adapt to changes in business priorities and effectively manage competing priorities.
Proficient in basic Office 365 suite applications.
Proficient with Veeva Vault.
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:
Relocation:
VISA Sponsorship:
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings: