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Manager, PV Partner Management, Clinical Safety & Pharmacovigilance (CSPV)
211 Mount Airy Rd Basking Ridge, NJ 07920 US
Job Description
Target Pay Rate: 50-67.86/hr **salary will be commensurate with expereince
Job Description:
This position is responsible for the management of PV regulatory intelligence
Dissemination, maintenance, and support of impact assessment of emerging global regulatory requirements collected from the PV Regulatory Intelligence vendor, CROs, and other sources. Collaborates with service providers responsible for Call Center, case processing for DSI products, both investigational and marketed, to ensure accurate assessment and timely reporting of safety information
This position also supports with DSI CSPV partnerships and contracts including vendor outsourcing agreements, partner contracts, and Pharmacovigilance Agreements (PVAs) / Safety Data Exchange Agreements (SDEAs).
Manage, maintain, and document collaborative & license partner safety agreements with counterparts from (license) partner companies.
Management of relationships with Contract Partners involving PV provisions and PV Information Exchange in Contractual Arrangements to ensure good Pharmacovigilance practice and regulatory compliance. Provides subject matter expertise and technical guidance on requirements to implement corrective and preventative actions to remediate non-conformance issues involving Reg intel, partners, CROs, and case processing vendors
Skills:
Please have candidates highlight: PV Operations and Systems, PV Agreements and contracts, and PV regulatory intelligence backgrounds. Experience in field and possesses knowledge of FDA and global regulations, project management, and clinical and safety databases.
1. Communicates effectively within the team, cross-functionally, regionally, and globally as applicable; demonstrates clear written communication skills with internal and external team/stakeholders.
2. Effectively manages shifting priorities; collaborates and communicates across functions to achieve critical priorities.
3. Possesses a comprehensive understanding of the functional roles for clinical safety and pharmacovigilance for investigational and marketed products.
Education:
- Bachelor's Degree Nursing, Pharmacy, Life Sciences, Health Care or related field required or
- Master's Degree Life Sciences
- PharmD Life Sciences
**CO/NY candidates may not be considered
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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