Responsible for writing aggregated safety reports within agreed timeframes and to a high standard of accuracy, and evaluation & quality check of Individual Case Safety Reports (ICSR), in compliance with DS&E business rules, standard operating procedures and global regulatory requirements. Lead Pharmacovigilance projects in collaboration with other DS&E functions to develop business solutions and meet regulatory requirements.
Lead Pharmacovigilance projects to develop business solutions and meet regulatory requirements, by directing the team, manage progress, quality and timely completion of deliverables, and reporting progress to DS&E management.
Author along with Global Medical Safety Physicians, regulatory periodic safety reports (Periodic Safety Update Reports, US Periodic Reports) for Novartis in-patent products: collecting, organizing, analyzing and presenting the data by means of DS&E templates and procedures.
Lead cross functional expert teams to fulfill Periodic Safety Report accountabilities (DRA, Clinical, Marketing).
Review emerging regulatory guidelines and legislations and identification of impact to DS&E processes.
Collaborate with licensing partners and Clinical Research Organizations to meet joint accountabilities.
Collaborate with Electronic Data Management team to reconcile Serious Adverse Events between the Clinical and Safety databases to meet joint accountabilities and enable locking of Clinical database.
Review global marketing programs and establish process for AEs collection with global marketing teams.
Review Risk Management Plans in coordination with Global Medical Safety groups and assess the operational feasibility and implications of Pharmacovigilance commitments.
Assess seriousness, causality and labeling of serious adverse events and quality check ICSRs to ensure accurate and consistent Argus data entry from source documents.
Alert the Medical Safety Physicians of potential safety issues and assist the Medical Safety
Physicians in monitoring the safety profile of products.
Key contributor to Safety Profiling Teams to ensure that case reports are accurately evaluated and databased, and authoring Product Specific Guidelines for assigned products.
Contribute to the preparation of Standard Operating Procedures
Participate in Health Authorities inspections and audits as Subject Matter Expert, and develop and implement Corrective and preventative Actions (CAPA) to address safety findings.
Act as Subject Matter Expert in cross-functional meetings.
Train and mentor new DS&E associates and associates from other line functions.
PhD or PharmaD desirable Bachelors or Master degree in Life sciences or Pharmacy / Advanced Nursing as a minimum requirement Fluency in English. Knowledge of other languages desirable. 3 to 4 years experience in drug safety / Development or closely related areas of responsibility Experience in safety document or medical writing Understanding of drug development process, GCP and medical terminology Strong negotiation and communication skills, and ability to operate effectively in an international environment and across line functions Strong organizational and project management skills, with an ability to lead work groups Ability to mentor and coach
To apply follow thee below link