Janssen Scientific Affairs, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for a Local Safety Officer to be located in Horsham, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Scientific Affairs, LLC is dedicated to providing medical information and consultative support to the Janssen pharmaceutical companies.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Local Safety Officer ensures that the Janssen Local Operating Companies pharmacovigilance (PV) activities are managed in compliance with local regulations and company policies/procedures at a local or regional level and in accordance with any PV agreements with 3rd party partners. He/she has an appropriate system of PV and Risk Management in place in order to assure appropriate oversight for products within his/her responsibility. This individual fosters strong collaboration and partnership with the Operating Company commercial business and Global Medical Safety (GMS). The Local Safety Officer will be responsible to ensure appropriate PV oversight through monitoring of performance and effectiveness of the PV and quality system(s) and to notify and consult with local management regarding emerging GMS initiatives, risks or remediation.
The Local Safety Officer will:
• Ensure that systems and processes are available for collection (initial and follow-up), review, reporting and reconciliation of Adverse Events (AEs), Adverse Events combined with Product Quality Complaints (AE+PQCs) and pregnancy reports obtained through the following sources: spontaneous, solicited, clinical trials, data generating activities, local Regulatory Authorities (RAs) and all other potential sources.
• Ensure that the LOC meets procedurally defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual case safety reports.
• Have oversight of data generating activities to ensure any solicitation for information includes an appropriate review and reporting process for reporting potential AEs (e.g. patient support programs, market research surveys, internet sites), as applicable.
• Have safety oversight of commercial projects conducted in the territory as applicable.
• Collaborate with Medical Affairs for the review and approval of safety aspects of local study protocols as requested or Patient Support Programs (PSP) and other clinical activities to ensure appropriate safety reporting to GMS or appropriate case management centre and RA, as required
• Maintain overall responsibility for the coordination of safety requirements to Regulatory Authorities as required for Marketing Authorization Holders (MAH).
• Plan and ensure timely submission of Aggregate Reports according to local regulations.
• Have an appropriate system of PV and Risk Management in place in order to assure appropriate oversight for the implementation of Risk Management Activities for products within its responsibility.
• Have involvement in implementation of Risk Management Plans and Urgent Safety Restrictions, if required.
• Coordinate the provision of support for third party safety agreements with PV implications at the local level and ensure the PV agreement is implemented locally, as appropriate
• Ensure PV inspection readiness on the LOC level at all times and assist inspectors/auditors with document requests.
• Collaborate with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the local RA to the appropriate global and regional groups as appropriate. Collaborate with appropriate departments to identify the resources and expertise needed to address the question. This may include local, regional and/or global expertise.
• Where applicable, support the QPPV to provide safety-related regulatory communication (e.g., response to request for information from local RAs, including the provision of information about the volume of sales or prescription, as appropriate.
• Provide technical and strategic input and participate in projects led by the regional PV team and IPV work streams.
• Ensure implementation of Global and Cross-Pharma Procedural Documents as applicable and/or write, validate and implement the Local Implementation Memos (LIM) for Regional / International PV Standard Operating Procedures/Working Practices and verify adherence.
• Ensure awareness of changes in regulations which may have an impact on PV activities and responsibilities. Evaluate the impact on local processes and inform the appropriate global and regional groups (i.e. QPPV offices and IPV Regional Heads) of any changes to local laws and regulations regarding PV.)Qualifications
• A minimum of a Bachelor's degree is required
• An advanced degree (i.e. Master’s, MBA, PhD, PharmD, etc.) is preferred
• A minimum of 10 years of experience is required, preferably in Medical or pharmaceutical sciences with proven expertise and experience in pharmaceutical regulations and R&D processes
• A minimum of 2 years of pharmaceutical industry experience with at least 1 year in a PV related role is required
• Sound knowledge of general medicine or pharmacy and clinical practice, or relevant scientific/medical field is required
• Proven ability to organize workflow activities and manage multiple critical issues is required
• Awareness of and familiarity with industry principles of PV is required
• Expert knowledge of Global, Regional and Local PV Procedural Documents as applicable is preferred
• Computer literate with knowledge of relevant IT safety systems required
• Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers is required
• Ability to establish and maintain open relationships within the organization and with authorities is required
• Demonstrable knowledge of all local PV requirements and of global aspects of drug safety is preferred
• This position will be located in Horsham, PA and will require up to 10% domestic and international travel
Janssen Scientific Affairs, LLC (6120)Job Function