Patient Safety Manager
2 weeks ago
Position Summary:
Is responsible for performing some or all of the required pharmacovigilance (PV) activities listed below in line with local regulatory and relevant legal requirements and COMPANY procedures, under the supervision of the LMPS Lead (or designee)
Position Responsibilities:
- Risk management plans
- Provision of safety information
- Implementation of PV Audit and Inspection Readiness
- Planning, processing and reporting of Aggregate Reports to HA and EC (as required)
- Maintenance of PV Awareness and Training -Implementation of Pharmacovigilance Agreements
- As applicable, collection, follow-up and forwarding of spontaneous, literature, solicited, post
- marketing AE cases
- Submission of single cases to local Health Agencies(HA) and Ethics Committees (as required)
- Local Market Safety Data Quality
- Note: for greater detail of the specific responsibilities and duties refer to the International Patient Safety Core Activities of the Local Market Patient Safety Personnel.
Experience Requirements:
- Minimum 3 years experience of working in the pharmaceutical industry in PV department.
Key Competency Requirements:
- Ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team locally, within Worldwide Patient Safety and externally.
- Develops a good understanding of the COMPANY organization, in particular the Global and Regional Safety groups. Has a good understanding of relevant local departments e.g. Regulatory and Clinical Teams and how these teams interact (or similar experience in another company).
- Possess excellent interpersonal, verbal, and written communication skills. Able to research, compile and provide safety information in a clear concise manner to the local /regional team and Worldwide Patient Safety HQ as appropriate. -An understanding of local, regional and any other relevant legislation with regard to PV (e.g. ICH, CIOMS), as well as COMPANY corporate and local systems (e.g. Global Safety Database, local data bases) and procedures, in order to fulfill regulatory requirements for pharmacovigilance.
- Maintains an awareness of the safety profile and any emerging pharmacovigilance/patient safety issues with COMPANY products (marketed or investigational )in the local affiliate and with support able to represent the local Patient Safety function on cross functional teams, providing input on drug safety issues.
- Demonstrated ability to review safety information with attention to detail and accuracy, while managing multiple tasks & prioritizing work in order to meet strict deadlines. Utilizes effective problem-solving approaches to solve PV issues, seeking support from supervisor when necessary. Ability to comply with relevant internal and external processes/guidelines/regulations.
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