Local Medical Safety Specialist

5 months ago

High Wycombe, United Kingdom Johnson & Johnson Full time

Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure, and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring pioneering science and the most creative minds in the industry together to think differently about diseases. We seek not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

We are recruiting for a Local Medical Safety Specialist, located in our High Wycombe office. This role falls under the J&J Hybrid working model which will allow you a mix of home
- and office-based work days. You will act to ensure the pro-active Benefit Risk Management (BRM) throughout the product life cycle, translating global safety data to insights and actions, and tailoring to local specificities and needs. Support activities related to safety reporting required by Marketing Authorisation Holders (MAH) and/or study sponsors, as applicable.

**Key Responsibilities**:
**Benefit Risk Management**:

- Establishing Product knowledge with a focus on safety profiles, Therapeutic Area, and Disease Pathway knowledge supporting the needs of the local Medical and Marketing organisation in collaboration with the International Medical Safety leader and the LSO;
- Acting as safety specialist in cross-functional team meetings and performing training on safety-relevant aspects, as appropriate;
- Providing Risk Management Plan status updates; preparing local RMPs/ Addendum etc.
- Involvement in the implementation of Risk Management Plans and Urgent Safety Restrictions, if required;
- Participating in meetings for the discussion and evaluation of topics related to benefit-risk and product safety, as required;
- Involvement in DHPCs management, submitting and tracking DHPCs to RAs(Regulatory Authority)/HCPs (if performed by IPV);
- Providing input into safety sections of local protocols (including Clinical Trials, Non-Interventional Studies, Research Related Activities, Patient Support Programs etc.) to ensure appropriate safety reporting as required by regulations;
- Performing concept and protocol review related to data generation activities - clinical and post-authorization studies (for Pharma in RECAP) and Local Safety Monitoring Plan (SMP);
- Medical/Pharmaceutical assessment of local individual cases when requested in partnership with global teams, if applicable;
- Undertaking appropriate actions such as site visits for special interest cases as requested by LSO;
- Support to implement CCDS into local labels (SmPC, patient leaflet, etc) when required.

**Aggregate reports**:

- Providing medical input and insights for aggregate reports;
- Supporting LSO to undertake the local review and ensure the submission of Periodic Safety Update Reports (PSURs/DSURs).
- Support LSO to develop and maintain an up-to-date list of all local authorities relevant to pharmacovigilance and, where applicable, other official bodies to which local safety reporting is requested by the authority;
**PV-Safety training support**:

- Performing Pharmacovigilance training for Local Operating Company employees;
- Performing training for local operating company employees covering (pharmacological) safety aspects of products as applicable;
- Performing training for local operating company employees covering follow-up process for concepts of special interest (Watchlist) as applicable;
- Managing AE/PQC training to distributors/vendors and translation of AE/PQC material, where needed.;
- Follow up for completion of global rollout AE/PQC training in LOC.

**PV contract management**:

- Managing local PVAs and ensuring local implementation, including Local Safety Unit (LSU) training and adherence to PVAs
- Functioning as IPV Lead reviewer, to have PVA implementation and oversight
- Coordinating the provision of support for third-party safety agreements locally e.g. local Vendor Agreements as necessary, seeking support from central functions like PV Service and Technical Contracts Group and HUB as necessary
- Providing and/ or reviewing quarterly listings for the PSMF Annex B (vendor agreements and commercial agreements) for agreements signed by the local Operating Company and ensuring accuracy and timeliness
- Supporting the LSO in taking responsibility for Products of Local Opportunity (POLOs) agreements, and supporting the implementation of the PV agreement locally, as appropriate.

**Safety regulations**:

- Reporting regulatory requiremen

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