The purpose of the Safety Officer (LSO) role is to run a local Pharmacovigilance (PV) system in the territory of responsibility in full compliance with all local and international PV regulations and to represent CSL Behring (CSLB) PV within specific countries.
The Safety Officer is responsible for Pharmacovigilance in the Group Latin American Distributors (GLAD) (Guatemala, Honduras, El Salvador, Panama, Costa Rica, Nicaragua, Colombia, Peru, Ecuador, Dominicans, Trinidad &Tobago, Barbados, Jamaica Puerto Rico, of responsibility and fulfils local PV regulations and obligations in line with international requirements and CSLB processes under the guidance of GCSP Regions.
Regardless of other roles performed by the same person, the role of the Safety Officer is strictly non- promotional and is underpinned by the principles of CSL’s Global Safety Governance System.
Main Responsibilities and Accountabilities : 1 - The key Safety Officer responsibilities in the Territory involve the establishment and maintenance of the local PV system, which includes (but is not limited to) : PV responsibility for all CSLB products licensed, marketed or supplied within Territory of responsibility.
PV compliance with local as well as international regulations (e.g. GVP) and inspection readiness. Maintain up-to-date information relevant for the Pharmacovigilance System Master File (PSMF).
Develops and implements local PV procedural documentation (in accordance with GCSP policies and procedures and the local document management system).
PV training for affiliate / Commercial Operations organization personnel as well as business partners in the territory. 2 -
Serves as the primary point of communication / interface between the CSLB affiliate and GCSP, ensuring a timely and two-
way communication platform is established (e.g. notification of safety relevant information). This includes the establishment of local process for the escalation of safety related issues / inquiries (including a process for handling out-
of- hours inquiries). He / she acts as the Primary PV contact for the local Competent Regulatory Authority in the Territory, collaborates with relevant interfaces (i.
e. Regulatory Affairs) in regards to communication between CSLB and the local Competent Regulatory Authority, facilitates communication from GCSP to the local Competent Regulatory Authority, ensures the communication of PV / safety related inquiries / regulatory actions and requests from Competent Regulatory Authorities are forwarded to GCSP as required.
3 - Responsible for implementing and maintaining PV related regulatory requirements defined in the applicable regulations of the Territory and informing GCSP regarding new PV / safety relevant regulations in the Territory.
This includes continuous monitoring of safety regulatory reporting requirements applicable in the territory and maintenance of up-
to-date information in the global Drug Safety Database (WAVES) System in close collaboration with GCSP Regions and the GCSP WAVES Team in line with relevant GCSP SOP.
4 - Responsible for Individual Case Safety Reports (ICSRs) handling (receipt, translation, timely reporting, tracking, follow-
up, document archiving, and reconciliation). This includes ICSRs identified from the local literature and from local Health Authorities.
5 - Responsible for timely and accurate submission of ICSRs and aggregate safety reports (as required) prepared by GCSP, to the Competent Regulatory Authorities in the Territory, and feed-
back on submissions to GCSP for compliance metrics. 6 - Manages the PV training requirements of affiliate personnel and personnel of Affiliate 3rd Parties, ensuring these personnel are aware of their PV reporting obligations.
Including : Development of training materials, Delivery of regular and ad-hoc training, Monitoring of training compliance.
7 - Ensure that a local business continuity plan exists so that ICSR handling can continue during a crisis. 8 - Provides a local interface between global GCSP organization and all local functions such as local Quality Assurance (QA) (LQO), to ensure timely reporting and handling of local product quality safety-
related information (e.g. Product Technical Complaints) and issues. Collaborates with LQO for the handling of affiliate deviations and CAPAs.
9 - Provides a local interface between global GCSP organization and local functions such as Commercial Operations / Medical Affairs (incl.
Medical information if applicable) / Commercial Development / Marketing, ensuring All product safety information incl. medical information inquiries received locally are screened and monitored for ICSRs / safety relevant information and handled in accordance with GCSP procedures.
Oversight of all Organized Data Collection System (ODCS) running in the territory including maintenance of global ODCS table.
PV compliance of all ODCS and business running in the territory (e.g. PVA). 10 - Assumes PV related responsibilities in CSLB sponsored / non-
sponsored interventional / non-interventional studies : For CSL sponsored interventional studies and CSL sponsored post authorization safety studies, the Serious Adverse Event (SAE) reporting responsibilities of the Safety Officer (if any) will be defined in the study specific SAE reporting plan.
For CSL post authorization safety studies (PASS) to be initiated by Commercial Development in the Territory (sponsored interventional / non-
interventional PASS, or Investigator initiated interventional / non-interventional PASS), the Safety Officer is responsible for informing GCSP about the study, and closely liaising with GCSP during the planning, performance and post-
study phases of the PASS, including updates on recruitment status as required for aggregate safety reports (e.g. DSUR). The Safety Officer must promptly provide the safety sections of such study reports and any publications to GCSP.
11 - Provides a local interface between global GCSP organization and all local functions such as local Regulatory Affairs, and the Country / Regional / General Manager to ensure timely implementation of Risk Minimization Measures in the territory.
This includes liaising with GCSP regarding the updating of safety sections within local product labeling and for interpreting the product labeling updates provided by GCSP into the local Prescribing Information and package inserts.
12 - In close liaison with the Global PV Agreements (PVA) team acts as PVA Owner within the Territory based on the applicable Supply / Distribution Agreements (Main Agreements) and related Quality Agreements with Partner Companies / 3rd Party Distributors in the Territory.
Develops the Local / Regional PVAs in close cooperation with the GCSP PV Agreements team, and is responsible for local PV Vendor selection and management in close collaboration with local Quality (LQO) as applicable.
Maintains the Local / Regional PVAs in CSLs contract management system (i.e. Companion). 13 - Promptly informs all relevant local functions and GCSP Regions about up-
coming PV- related inspections of the Affiliate by any Competent Regulatory Authorities in the Territory. (This includes GMP, PV and relevant GCP inspections).
Closely liaises with the relevant functions in the preparation and during the conduct of the inspection, and for appropriate CAPA follow-
up. 14 - Participates in the Clinical Quality Assurance (CQA) PV Audit schedule and assists in audit preparation activities, including the development of a CAPA plan and the close out of any audit action items.
In addition the Safety Officer provides support to other CSL functions (e.g., QA, CQA) in the auditing of external customers within the Territory where PV and Safety risk management fall within the scope of the audit plan.
The Safety Officer acts as follow-up coordinator for PV audits at the affiliate or at business partners in his / her territory.
with working experience in nominated discipline. Fluent in the Spanish / English language Experience Medical, PV and / or Regulatory experience in the Pharmaceutical or Biotechnology industry Expert knowledge of the PV relevant regulatory framework in the Territory, and sound knowledge of international PV relevant regulations and standards Additional Comments : CSLB Safety Officer must be fluent in English to ensure proper translation of safety information into English and to communicate within the Safety Officer network and with GCSP The Safety Officer is nominated by the Country / Regional General Manager responsible for the respective Affiliate and by the GCSP Regions Lead responsible for the territory.
Depending on e.g. the number of products licensed / marketed in the Territory, the size of the Territory, the complexity of the applicable regulatory requirements in the Territory, the number of Partner Companies / 3rd Party Distributors in the Territory, the Safety Officer role can be a part-
time or full-time position. The Safety Officer may have additional Affiliate roles such as Local Affiliate Medical Manager and / or Regulatory Manager, and / or Quality Manager.
LI-TD1 Worker Type : Employee Worker Sub Type : Regular