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Clinical Safety
2 months ago
Job Title: Pharmacovigilance Partner Management, Clinical Safety & Pharmacovigilance (CSPV) Manager
Duration: 12+ Months (Possibility of extension & conversion)
Location: Basking Ridge, NJ
Job Schedule: 1 day Onsite/week – Possibility to go 100% Remote
Pay -$
Note: Local is preferred with ability to come onsite 1 time per week, 100% remote may also be possible.
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 client’s products, both investigational and marketed, to ensure accurate assessment and timely reporting of safety information
- This position also supports with client’s 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 Client, partners, CROs, and case processing vendors
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.
- Communicates effectively within the team, cross-functionally, regionally, and globally as applicable; demonstrates clear written communication skills with internal and external team/stakeholders.
- Effectively manages shifting priorities; collaborates and communicates across functions to achieve critical priorities.
- 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
We also encourage you to share this opportunity with friends or colleagues who may be a good fit for the role.
Your assistance in this regard would be greatly appreciated
