Join to apply for the PV Operations Specialist role at Planet Pharma
Join to apply for the PV Operations Specialist role at Planet Pharma
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.
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.
Qualifications:
- Bachelors 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 Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Seniority level
- Seniority level Not Applicable
Employment type
- Employment type Full-time
Job function
- Job function Management and Manufacturing
- Industries Staffing and Recruiting
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