Skip to content

Job Openings

Manager, PV Partner Management, Clinical Safety & Pharmacovigilance (CSPV)

Basking Ridge, NJ 07920

Posted: 09/26/2024 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 614964 Is job remote?: Yes Country: United States

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 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About Basking Ridge, NJ

Discover exciting job opportunities in the vibrant area surrounding Basking Ridge, New Jersey! Known for its picturesque landscapes, rich history, and thriving business community, Basking Ridge offers an unparalleled quality of life for professionals seeking growth and success. With easy access to NYC and iconic landmarks like the historic Jacobus Vanderveer House and the stunning Scherman Hoffman Wildlife Sanctuary, this charming region provides a perfect blend of career prospects and leisure pursuits. Indulge in locally sourced cuisine, catch a show at the elegant Ridge Performing Arts Center, or explore the natural beauty of Lord Stirling Park. Embrace the unique culture and endless possibilities that Basking Ridge has to offer as you explore our latest job listings and embark on a fulfilling career journey in this enchanting area.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.