Local Medical Safety Specialist - Janssen Pharmaceuticals - Beerse
Johnson & Johnson Family of Companies
Région
Beerse
Ensure the pro-active Benefit Risk Management throughout product life cycle translating global safety data to insights and actions tailoring to local specificities and needs.
Support activities related to safety reporting requirements as required by Marketing Authorization Holders (MAH) and/or study sponsor, as applicable.
Benefit Risk Management
- Establish Product knowledge with focus on safety profiles, Therapeutic Area and Disease Pathway knowledge supporting the needs of the local Medical and Marketing organization in collaboration with the International Medical Safety leader or MSO and the Local Safety Officer (LSO) if applicable
- Act as safety expert in cross-functional team meetings and perform training on safety relevant aspects, as appropriate;
- Provide Risk Management Plan status updates;
- Prepare Local RMPs/ Addendums etc (if performed by IPV);
- Involvement in implementation of Risk Management Plans and Urgent Safety Restrictions, if required;
- Participate in meetings with relevant stakeholders for discussion and evaluation of topics related to benefit risk and product safety as required;
- Involvement in DHPCs management, submit and track DHPCs to RAs (Regulatory Authority)/HCPs (if performed by IPV);
- Provide 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;
- Perform 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;
- Undertake appropriate actions such as site visits for special interest cases as requested by LSO;
- Support to implement CCDS into local label (SmPC, patient Leaflet etc) when required;
Aggregate reports
- Provide medical input and insights for aggregate reports;
- Support LSO to undertake local review and ensure the submission of Periodic Safety Update Reports (PSURs/DSURs) if applicable.
- 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;
- When applicable, for “Products for Local Opportunity” (POLOs), when Global Medical Safety (GMS) or OCMS does not provide the Aggregate Reports, support the LSO in ensuring the specific reports (e.g. PSUR) are prepared if not already provided by a third party under a PV agreement.
PV-Safety training support
- Perform Pharmacovigilance training for Local Operating Company employees;
- Perform training for Local Operating Company employees covering (pharmacological) safety aspects of products as applicable;
- Perform training for Local Operating Company employees covering follow-up process for concepts of special interest (Watchlist) as applicable;
- Manage AE/PQC trainings to distributors/vendors and translation of AE/PQC material, where needed.;
PV contract management
- Management of local PVAs and ensure local implementation, including LSU training and adherence to PVAs
- Function as IPV Lead reviewer, to have PVA implementation and oversight
- Coordinate the provision of support for third party safety agreements locally e.g. local Vendor Agreements as necessary, seek support from central functions like PV Service and Technical Contracts Group and HUB as necessary
- Provide and/ or review quarterly listings for the PSMF Annex B (vendor agreements and commercial agreements) for agreements signed by local Opco and ensure accuracy and timeliness
- Support the LSO in taking responsibility for Products of Local Opportunity (POLOs) agreements, and support the implementation of the PV agreement locally, as appropriate.
Safety regulations
- Report regulatory requirements for MAH and/or study sponsor as applicable as per process.
- Support the review of new/revised safety regulations (for drugs and non-medicinal products in scope of responsibilities), evaluation of the impact on local processes and notification of appropriate global and regional groups via central PV policy tracker about changes in local regulatory safety including cosmetics and medical device safety reporting requirements
- Implementation of new legislations with local impact for IPV owned activities, depending on topics
- Focused engagement in local industry associations and drive local policy shaping initiatives based on One J&J Voice.
Local Communications
- Work with the LSO and with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the local RA to the appropriate global and regional groups (GMS Support Desk, GMS Physician, OCMS, QPPV Offices, VP PV & Medical Compliance) as appropriate. This may include local, regional and/or global expertise
- Support the Qualified Person (QP), the LSO to provide safety-related regulatory communication (e.g., response to request for information from Local RA)
Local Safety compliance (PV and non-medicinal product safety)
- Provide insights into metrics to LSO, lead actions as needed
- Act as CAPA Content owner and subject matter expert, own actions as required - depending on topic
- Procedural Document review from SMEs and Area leads - depending on topic. Perform Impact assessments and action as required on local level - depending on topic
- Provide content for the IPV PSMF contributions and data, as required, on time and in high quality, ensure accuracy
- Responsible for the local PSMF implementation and maintenance, where applicable
- Collaborate with local/cluster case management team to ensure Local Operating Company/ Local Safety Unit audit and inspection readiness
Pharmacovigilance and Vigilance Service Provision
- Collaborate with LSO to ensure that day-to-day Pharmacovigilance activities and safety activities for non-medicinal products (i.e. cosmetics, medical devices, commodities, nutritionals) are performed satisfactorily, and that full regulatory compliance is maintained at Local Operating Company level including adequate record management
- Collaborate with the local Marketing Authorization Holder (MAH) to enable fulfilment of its regulatory responsibilities (including Pharmacovigilance Agreement (PVA’s)) and meet their business objectives
- Collaborate with LSO to ensure day to day safety for non-medicinal products and PV activities are performed satisfactorily including translation, follow up request, local literature review, submission to RA, as applicable.
- Act as back up of the Local Safety Officer/ Local Qualified person in PV for [country], ensuring that the Local Operating Company vigilance activities are managed in compliance with local regulation
Qualifications
Essential Knowledge & Skills
- Scientific/ life-science background, medicinal knowledge preferred; proficiency in Medical terminology (local languages).
- Ability to manage multiple critical issues.
- Computer literate with basic knowledge of GMS database systems.
- Awareness of and familiarity with industry principles of drug development and pharmacology
- Proficiency in global and local SOPs
- Good verbal and written communication skills, fluency in local language(s) and English language required.
- Ability to negotiate and communicate with internal and external customers. Ability to establish and maintain open relationships within the organisation and with authorities.
- Demonstrable knowledge of all local PV requirements and of Global aspects of drug safety.
Experience
- Scientific study and experience in pharmaceutical regulations and R&D processes.
- Pharmaceutical industry experience including a PV responsibility role required
Primary Location
Belgium-Antwerp-Beerse-
Organization
Janssen Cilag N.V./S.A. (7025)
Job Function
R&D
Requisition ID
2005832113W