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J&J Family of Companies Senior Local Medical Safety Specialist in Chile

Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies is currently recruiting for a Senior Local Medical Safety Specialist located in Titusville, NJ or anywhere in the continental United States, Canada, Latin America or Caribbean.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @ Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

The Senior Local Medical Safety Specialist will 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. He/She will support activities related to safety reporting requirements as required by Marketing Authorization Holders (MAH) and/or study sponsor, as applicable.

Responsibilities:

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);

  • Involvement in local safety signal detection, if applicable;

  • 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);

  • Provide support to HUB for local RRA;

  • 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

  • Follow up for completion of global roll out AE/PQC training in LOC

    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

Qualifications

  • Minimum of Bachelor's degree or equivalent in a health care related is required

  • Minimum of 3+ years of relevant experience

  • Experience with Pharmacovigilance, Cosmetovigilance or Medical Device Vvigilance experience is preferred

  • Experience as a Local Safety Officer or Medical Affairs role is preferred

  • Up to 10% domestic travel is required

    Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability

Primary Location

United States-New Jersey-Titusville-1125 Trenton Harbourton Road

Other Locations

Latin America-Panama, Latin America-Peru, Latin America-Brazil, North America-Canada, Latin America-Chile, Latin America-Colombia, Latin America-Costa Rica, Latin America-Ecuador, Latin America-Mexico, Latin America-Paraguay, Latin America-Uruguay, North America-United States, Latin America-Argentina

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2105919628W

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