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 

Job Tags

Remote job, Contract work, Shift work,

Similar Jobs