Local Safety Responsible-Levant (1 Year)
This document highlights the Key Responsibilities of the Local Safety Responsible (LSR) and is mandatory for implementation in the LSR Job Description. Adaptation is possible in accordance with affiliate structure, resources and other local requirements. If the LSR has any other functional role (Medical Information Manager, SAE Responsible, RMP Implementation Coordinator, PV Commitment Responsible, line management responsibilities etc.), these additional responsibilities must also be included in the LSR JD.
The locally adapted JD must be approved by the PV Country Cluster Lead, signed and dated by the LSR, LSR’s Line Manager and HR (if applicable) and filed in accordance with local and global requirements.
This JD forms the basis of the training plan.
The Local Safety Responsible (LSR)
- Is an affiliate role, i.e., holds responsibility for an affiliate and, if applicable, additional countries as per Pharmacovigilance System Master File (PSMF)
- Reports to: Country Medical Director (solid line), Global Head of IPV through the Country Cluster Leads (dotted line)
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- Ensures that collection, reporting and handling of safety information associated with Roche products is performed according to global Roche and local regulatory requirements.
- Maintains oversight of the management of safety information, safety risk management and all other pharmacovigilance (PV) activities, ensuring PV medical compliance (Roche policies and procedures, global and local regulatory requirements) and inspection readiness for country(ies) within their area of responsibility.
Key Activities and Responsibilities
Key activities include but are not limited to (for detailed information, please refer to Roche PV Policy/SOPs and Affiliate PV Manual, which contains PV standards for LSR/LSU activities):
I. Management of Individual Case Safety Report (ICSR) from all relevant sources (solicited and unsolicited sources)
II. Local Signal Detection for local products (i.e., products without global product support), where applicable
III. Oversight of PV Medical Compliance Risk Management Plan Implementation
- Contributes to development of local RMP and ensures oversight of its implementation in collaboration with relevant staff in accordance with Roche policies and procedures, global and local regulatory requirements.
IV. Safety Communication
- Ensures that management of safety queries, other significant safety issues and, if applicable, local/global crises is performed according to global Roche and local regulatory authority requirements.
- Acts as a point of contact for local Health Authorities and ensures communication of relevant safety information to external key stakeholders (as applicable).
- Maintains oversight of the Direct Healthcare Professional Communication (DHPC), Dear Investigator Letter (DIL) and To Whom It May Concern Letter (TWIMCL) processes.
- Provides QPPV office with all relevant information to allow their oversight and follow up on requests from the QPPV office as applicable
- Keeps up to date with local regulations and acts as nominated person for PV (or local QPPV) if and as required by local regulations
V. Study and Program Oversight
- Ensures appropriate safety reporting processes are in place at affiliate level and, if applicable, described in relevant local documents, for global and local interventional clinical trials, Non-Interventional Studies (NISs), Post Authorization Studies (PASS/PAES), Market Research and Patient Support Programs (MAPs), Pre-Approval and Post-Trial Access Programs and Compassionate Use in accordance with Roche policies and procedures, global and local regulatory requirements.
VI. Management of Aggregate Reports
- Provides safety related information to global teams for the preparation of Aggregate Reports, where applicable.
- Ensures preparation of Aggregate Reports for local products, where applicable, in collaboration with local Drug Regulatory Affairs.
- Maintains oversight of submission of PSURs/PBRERs and DSURs/SSRs (as applicable) to local regulatory authorities in accordance with Roche policies and procedures, global and local regulatory requirements.
VII. PV Quality
- Ensures collection and analysis of PV metrics and KPIs.
- Provides input on the PV KPIs for discussion, including at formal affiliate Management Reviews.
- Maintains oversight and provides reports to relevant stakeholders and senior management on the local PV system performance.
- Act as SME for any affiliate PV-related CAPAs
- Acts as the Local Process Owner for PV-related local processes and procedures.
VIII. Contract Review and PV Agreements
- Reviews contracts and provides input on necessary clauses/sections/wording for ensuring PV medical compliance.
- Reviews and approves the safety clauses/sections/wording in local commercial agreements. Ensures preparation and execution of PV Agreements, where necessary.
- Maintains oversight of PV activities as outlined in the PVA for local commercial agreements.
IX. Labelling and PV Commitments
- Ensures awareness of and contributes as applicable to local safety label updates.
- Contributes to the implementation of PV commitments, when applicable.
X. PV Oversight Of Countries With No Roche Presence (where applicable)
- Ensures oversight and tracking of PV activities in all countries under the LSR responsibility
XI. Management of the Local Safety Unit (as applicable)
- Leads a team of motivated individuals and promotes PV standards across the local organisation
- Ensures an adequate level of PV expertise of the LSU members, and provides training and development opportunities for the LSU members as appropriate.
- Ensures PV activities are properly resourced and escalates issues when required.
- Plans proper headcount to ensure adequate resourcing and business continuity.
XII Monitoring and Oversight of Service Provider Management/Outsourcing process
- Provides input for the relevant service provider Functional Oversight Responsible (FOR) to ensure that PV requirements are met
- Acts as a FOR for GVP service providers, as applicable.
XIII PV Approver for Market Research and Patient Support Programs (MAPs)
- Ensures that a PV Approver for Market Research and Patient Support Programs (MAPs) is in place
XIV National Contact Person for PV and local PSMF
- Acts as the national contact person for pharmacovigilance issues for <insert country name here>
- Is the direct contact for the <insert relevant Health Authority> for the handling of safety queries and other significant local safety issues
- Ensures a local Pharmacovigilance System Maintenance Master File (PSMF), where needed, is developed and maintained in conjunction with PV Governance, Policy & QPPV Office (GPQO).
Key Relationships (excluding direct line management)
Key Relationships may include but are not limited to the following:
Location: Location agnostic
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Research & Development, Research & Development > Drug Safety