Benefit Risk Management
• Establish Product knowledge with focus on safety profiles, Therapeutic Area and Disease Pathway knowledge supporting the needs of the local Medical Affairs and Marketing organization in collaboration with the International Medical Safety leader;
• Act as safety expert in cross-functional team meetings and perform training on safety relevant aspects, as appropriate;
• Provide Risk Management Plan (RMP) status updates;
• Prepare local RMPs/Addendums, etc. as applicable;
• Involvement in implementation of RMPs and Urgent Safety Restrictions (USR), if required;
• Participate in meetings with relevant stakeholders for discussion and evaluation of topics related to benefit risk and product safety;
• Involvement in local safety signal detection, if applicable;
• Take appropriate measures to ensure that new safety information is available to HA and Healthcare Professionals (HCPs) in a timely manner, i.e. Direct Healthcare Professional Communication (DHPC), company core datasheet (CCDS) implementation into local label, USR if applicable.
• Involvement in DHPCs management, submit and track DHPCs to HAs/HCPs, as applicable;
• Support to implement CCDS into local label, when required.
• Provide input into safety sections of local protocols (including Clinical Trials, Non-Interventional Studies, RRAs, PSPs 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 safety input and review of regulatory submission dossier for CTA and NDA/BLA
• Medical safety review of individual cases from global safety database when requested;
• Provide medical input and insights for aggregate reports;
• Provide medical insight for global aggregate reports and prepare local aggregate report as per local regulation/local health authority requirement
Local Medical Safety training support
• Perform PV training for LOC employees covering (pharmacological) safety aspects of products and follow-up process for concepts of special interest (Watchlist);
Collaboration & Support
• Collaborate with Regulatory Affairs to forward any safety-related inquiry or relevant communication from the local HA to the appropriate global and regional groups (GMS Support Desk, GMS Physician, QPPV Offices, VP PV & Medical Compliance) 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.
• Support the Qualified Person (QP) to provide safety-related regulatory communication (e.g., response to request for information from local HA, including the provision of information about the volume of sales or prescription, as appropriate), as applicable. Has a free access to the QPPV to raise any compliance or safety issues independently of the reporting lines.
• Participate in the Product Issue Management teams, as appropriate.
• Provide technical and strategic input and participate in projects led by the regional GMS team and GMS work streams.
• Provide timely and accurately PSMF contribution.
• Ensure adequate process is established for the implementation and the maintenance of the local “PSMF” as applicable.
PV regulations monitoring & implementation
• Ensure awareness of changes in regulations which may have an impact on vigilance activities and responsibilities and report regulatory requirements for MAH and/or study sponsor as applicable as per process.
• Review and evaluation of the impact of new/revised PV regulations 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.
Shaping regulatory environment
• Focused engagement in local industry associations and drive local policy shaping initiatives based on One J&J Voice.
Audit & inspection readiness
• Act as the local PV contact person for all PV audits and inspection and coordinate the audit and inspection preparations for internal PV audits (e.g. Bioresearch, Quality & Compliance (BRQC)) and external PV inspections.
• Assist inspectors/auditors; support document requests in collaboration with relevant stakeholders.
• Address follow-up actions from findings.
• Ensure that any HA communications are forwarded to the required PV personnel and that any responses/corrective actions are tracked and completed according to schedule.
EDUCATION & EXPERIENCE REQUIREMENTS:
Essential Knowledge & Skills
• Sound knowledge of general medicine or pharmacy or clinical practice, scientific/life-science background, medicinal knowledge preferred; proficiency in Medical terminology (local languages).
• Proven ability to organize workflow activities and manage multiple critical issues.
• Computer literate with basic knowledge of safety database systems.
• Awareness of and familiarity with industry principles of drug development and pharmacology
• 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.
• Scientific study and experience in pharmaceutical regulations and R&D processes.
• Pharmaceutical industry experience including a PV responsibility role required.