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PV Operations Specialist
Job Description
Job Summary:
Reporting to the Head of Drug Safety and Pharmacovigilance Operations, the PV Operations Specialist will play a key role in drug safety Individual Case Safety Report processing across the clinical development programs, contributes to the day-to-day operational activities of the department and ensures that performed tasks comply with company SOPs and policies, best industry standards and applicable regulations.
Responsibilities:
- Participate in assigned clinical study team meetings to provide pharmacovigilance support.
- Liaison with PV Operations and other teams (i.e. study teams) on execution of study deliverables (i.e. study start up, safety management plans, SAE reconciliation, query management, TMF), aggregate reporting and post marketing activities, as required.
- Participated in sponsor oversight of Adverse Event/Serious adverse event processing and reconciliations by outsourced vendors, including the review of Individual Case Safety Report processing (case triage, data entry, coding review, sponsor approval and narrative writing), as well as monitoring of Individual Case Safety Report reporting within the Company Sponsored Safety Database.
- Oversee vendor relationships and ensure compliance with vendor agreements
- Assist with audit and inspection preparations, provide data for investigators upon request
- Supports monitoring of Quality of vendor of Individual Case Safety Report processing for clinical and post marketing cases
- Support the monitoring and performing of notification and/or submissions for Individual Case Safety Reporting for Clinical Trial submission cross functionally (e.g. CRO, Partner, Clinical, and/or Regulatory) with DSPV Systems Team
- Support PV Operations & Compliance with monitoring reports (i.e. KPI) and other oversight activities and ensure the implementation of effective corrective and preventative action plans.
- Supports the quality management system in Drug Safety including ensuring department standards are met, including training requirements, monitoring performance, implementing continuous improvement actions and good documentation practices.
- Supports the daily management and execution of Drug Safety and Pharmacovigilance operations cross functionally.
- Additional safety related duties assigned.
- Bachelor’s degree in nursing, pharmacy, or other health care related profession or life sciences.
- Minimum of 3 years of Drug Safety/Pharmacovigilance case process in a pharmaceutical industry setting.
- Prior experience working with CROs, vendors, and relationship management preferred.
- Argus database experience with implementation, migration to and ongoing management
- Global pharmacovigilance operations experience with products in development.
- Knowledge of ICH Good Pharmacovigilance Practices and Good Clinical Practices.
- Anticipate and proactively resolve issues when and where possible.
- Knowledge of FDA and EU legislation and ICH Efficacy guidelines.
- Strong analytical, problem-solving skills with superb attention to detail, and able to organize workload to prioritize most urgent deliverable.
- Strong verbal, written technical communication and presentation skills.
- Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
- Proven ability to work within a cross-functional, matrixed team.
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 is an equal opportunity employer. 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.
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