PHARMACOVIGILANCE ASSOCIATE MANAGER (Local Safety Officer) | JANSSEN

Job description

Job Description

Requisition ID: 0078181214


Act as Local Safety Officer (LSO) and as a local nominated contact for PV, which has a primary responsibility of ensuring that the LOC PV activities are managed in compliance with local regulations and company policies/procedures at a local, regional and global level and in accordance with any PV agreements with third party business partners. Having an appropriate system of PV and Risk Management in place to assure appropriate oversight for products within its responsibility.

1. Safety Management and Reporting

·  Key responsibility is to 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 special reporting situation (SS) obtained through the following sources: spontaneous, solicited, clinical trials, data generating activities, local Regulatory Authorities (RAs) and all other potential sources. Accountable internally for ensuring that the LOC meets procedurally defined timelines for management of safety information and any local regulatory agency defined timeline for submission of individual reports.
·  Collaboration with Medical Affairs, clinical groups or other applicable groups for proper 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 and safety oversight of clinical trial projects.
·  Maintain overall responsibility for the coordination of safety requirements as required for Marketing Authorization Holders (MAH) in accordance with local regulation, including aggregate reporting planning and submission.
·  Creation and implementation of PV business continuity plans (e.g. inspection readiness, AE reporting coverage).
·  Oversight responsibilities of case processing operational activities delegated to the Center of Excellence Case Processing hub for Latin America or external vendor as appropriate. Case processing activities include but not limited to Inbound reporting, outbound reporting, translation of AEs/Special Reporting Situations/PQCs, literature search, due diligence.
2. Pharmacovigilance Service Provision


·  Assure the all safety-related third-party agreements have appropriate Pharmacovigilance language incorporated and proper implementation at local level of those with PV implications; in addition, ensure that these contracts are archived in the global system, as applicable.
·  Ensure commercial partnerships (including Tech Trasnfers) are properly assessed for PV impact.
·  Ensure PV inspection readiness on the LOC level at all times.
·  Address follow-up actions from findings; monitor non-LSO safety-related corrective actions.
·  Management of self-identified CAPAs for PV system non-conformances identified in the territory of responsibility.
·  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.
·  Close connection with the Local Operating Company including but not limited to Medical Affairs, Business Quality, Business Intelligence, Marketing and Sales. Participate in projects, leadership meetings and management reviews as appropriate.
3. People Management

·  Ensure proper documented training on drug safety reporting responsibilities of Janssen LOC personnel and maintenance of awareness of drug safety reporting in general.
·  Manage and direct local safety staff providing coaching and feedback, if applicable.
4. Process and Regulation

·  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.
·  Active participation in local Pharma entities (Interfarma and Sindusfarma).

Desired profile

Qualifications

·  Sound knowledge of general medicine or pharmacy and clinical practice, or relevant scientific/medical field.
·  Proven ability to organise workflow activities and manage multiple critical issues.
·  Awareness of and familiarity with industry principles of PV, drug development and pharmacology.
·  Expert knowledge of Global, Regional and Local PV Procedural Documents as applicable.
·  Computer literate with knowledge of relevant IT safety systems.
·  Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external customers.
·  Ability to establish and maintain open relationships within the organization and with authorities.
·  Demonstrable knowledge of all local PV requirements and of global aspects of drug safety.
·  Fluency in the national language(s) and the English language is required.
·  Medical or pharmaceutical sciences with proven expertise and experience in pharmaceutical regulations and R&D processes is preferred.
·  By preference a minimum of 2 + years pharmaceutical industry experience with at least 1 year in a PV responsibility role.
Primary Location
Brazil-São Paulo-São Paulo-
Organization
Janssen Cilag Farmaceutica Ltda. (7585)
Job Function
Regulatory Affairs
Requisition ID
0078181214