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Drug Safety Officer
2 months ago
Russell Tobin & Associates is supporting a world-class pharmaceutical organization that has an opening for a Pharmacovigilance (PV) Safety Officer near King of Prussia, PA.
Responsibilities
- Liaises with multiple people within the US Commercial and/or Global Commercial teams who are to inform the Safety Officer about any new Organized Data Collection System (ODCS) programs.
- Responsible for maintenance and of the global ODCS entries of the programs involving USA via HaloPV to ensure compliance with the PSMF (Pharmacovigilance System Master File) obligations.
- Reviews and comments on questionnaires/surveys/discussion guides for any potential questions that would elicit safety information (i.e. adverse events) which will be used in an ODCS program.
- Provides insights for process improvement and management of HaloPV and handling procedural documents.
- Supports implementation of Pharmacovigilance Agreements (PVAs)
- Reviews and provides input/comments to the PVAs in close cooperation with the GPAA.
- Negotiates the terms of the PVA with the 3rd Party Service Providers. If needed, bring Legal into the PVA negotiations with the Service Providers.
- Notifies GPAA with confirmation & reason to terminate a PVA.
- Training of 3rd Party Service Providers
- Inspection/audit readiness
Requirements
- Bachelor’s degree (e.g. in biological, nursing, healthcare or pharmaceutical sciences, quality or equivalent)
- 3+ years in pharma industry / pharmacovigilance
- Knowledge of US FDA regulations pertaining to pharmacovigilance
- Familiarity with international standards and regulatory requirements/regulations related to pharmacovigilance and Good Clinical Practices
Additional Notes:
- Hybrid position – Must be onsite 50% of the time and must be onsite at least Tuesday and Wednesday weekly
- Position type: 1 year contract
- Pay rate range approved: $65-80/hr depending on experience
Must be authorized to work in the United States.
Russell Tobin offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.
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About Us
Russell Tobin is a leading minority-owned professional and technical recruitment and staffing advisory organization.
We are comprised of specialized practices focusing on a variety of skill sets and industries. Having a depth and breadth of industry expertise, our subject matter experts are able to provide tailored and swift sourcing solutions to fulfill client hiring needs. In other words, we connect top talent with companies.
We are the staffing arm of the Pride Global network, a minority-owned integrated human capital solutions firm, with additional offerings in vendor management, payroll programs, and business process optimization.
As a certified minority-owned business, Pride Global and its affiliates - including Russell Tobin, Pride Health, and Pride Now - are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics.
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