Patient Safety Manager

2 weeks ago

Midrand, South Africa Sandoz Full time

Your responsibilities include, but not limited to:

- **Leadership**:Build strong relationships with relevant functions in the affiliate organization (including but not limited to regulatory affairs, medical affairs, quality assurance, marketing and sales, clinical development and others), in collaboration with the Director Patient Safety HUB/ Associated Director Patient Safety HUB and 3rd party vendors.
- **Communication flow**:In collaboration with the Sandoz regional Hubs and the 3rd party vendor operational hubs, ensure that communication flows for safety processes including any **local sources of safety data **and **safety issues **are identified and implemented.
- **Single point of contact [and 24hr availability]**:As defined by local regulations act as the National/Local Qualified Person or Local Contact Person for Pharmacovigilance in the country(ies) and act as the single point of contact with the Local Health Authority [on a 24-hour basis where required].
- **Management of Safety Information**
- **Management of Adverse Events**:Ensure the local management of adverse event information, with the following aspects (In collaboration with 3rd party vendor routine operational activities may be partially or completely outsourced):

- Identification of sources of adverse event information, from any source in the country
- Maintaining oversight on case content and reporting.
- **Product Complaints management**: Maintain awareness of product complaints received in the affiliate, ensure exchange and reconciliation of product complaints associated with adverse events.
- **Management of Periodic reports**:In collaboration with other local, regional and global functions, ensure the planning of periodic reports to meet local compliance obligations, maintain oversight on submission of reports authored by global functions.
- **Management of Local Literature**:In collaboration with 3rd party vendor, identify the local journals required for screening, maintain overview on search results specifically any potential safety signals or aspects relating to benefit/risk.
- **Support business in the set-up of programs **and any other activities that may elicit adverse event and other safety relevant information by collaborating in the set-up of programs/projects and implementation of reporting pathways, including data reconciliation and source data verification.
- **Sandoz product safety profiles and related actions**
- **Health Authority Requests (and other externally generated signals)**:In collaboration with 3rd party vendor, Regulatory Affairs (RA) and other functions, ensure processes are in place to answer fully and promptly any safety related requests from Local Health Authorities.
- **Awareness of Sandoz product safety profiles**:Maintain oversight on results of the signal management process, including any relevant subsequent actions, such as safety variations, ARMM, or ad hoc safety measures.
- **Risk Management**: Cooperation and oversight of the implementation of local RMP commitments and effectiveness checks. Ensure the country oversight of implementation of Post Authorization Safety Studies and additional Risk Minimization Measures at local level.
- **Ad hoc Safety Measures**: Ensure readiness to implement ad hoc safety measures such as emerging safety issue notification, Direct HCP or Patient communication, Urgent Safety Restrictions, Product Recall for Safety or Quality reasons
- **QMS and supporting processes**
- **Local Procedures**:Ensure the local Pharmacovigilance requirements are met. Identify specific requirements that may not be covered by global procedures and communicate to the Sandoz regional hub. Where required, implement local procedures to supplement PS global procedures and to ensure compliance national requirements.
- **Trainings**:Ensure that all local internal and external stakeholders are adequately trained from pharmacovigilance obligations.
- **Records management**:Ensure access to all records are maintained to oversee the flow of safety information at local level.
- **Compliance Management**:Participate in compliance governance to monitor internal compliance for local processing and external compliance.
- **Audits and Inspections**:In cooperation with the 3rd party vendor, QA and other applicable groups, maintain audit/inspection readiness with the support of regional hubs and 3rd party vendor and manage any local Pharmacovigilance audit/inspection. Contribute as Pharmacovigilance SME, in other internal Sandoz audits and/or third-party audits, as applicable.
- **Deviation and CAPA**:Identify and document local deviations and proactively, cooperate in the implementation of any corrective/ preventative action as determined by root cause analysis and CAPA plans.
- **PSMF/PSSF**: Where required, prepare and maintain the PSMF/PSSF, with input from global functions and 3rd party vendor
- **PV Agreements**:Input, review, and approval of program proposals for language, content and establishment

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