CHC - PV Literature Surveillance Lead - All Gender at Sanofi

• CHC PV Literature Surveillance lead is a Leadership member of the CHC PV Operations team and reports to the CHC PV Operations Head
• This position includes responsibilities for the oversight of global Literature Screening in support of ICSR, Periodic Reporting and Signal/Risk Management
• This position is responsible for providing the strategic vision, planning and oversight on publishing of all CHC PV regulatory documents
• This position maintains oversight and responsibility for global publishing vendors

Key results/accountabilities

• Responsible for the medical evaluation of complex scientific and medical literature publications encompassing all types of publications including study publications for clinical studies - for all CHC products
• These publications are identified by approved screening criteria from various sources including numerous external databases and from license partners
• The medical evaluation of the publications ensures high medical quality and compliance with health authority requirements regarding literature review and single case handling

Supervise and support the work of vendor team performing PV literature surveillance activities according to appropriate regulations and agreed processes as listed below

• Perform end-to-end literature review and make the determination if the article is relevant for signal detection and/or inclusion in periodic reports and/or contains an ICSR (detection and narrative writing)
• maintaining and documenting up-to-date product knowledge to aid in literature review
• creating and maintaining literature search strategies (in house or in collaboration with vendors)
• Identifies critical case reports and other medical and scientific publications that require immediate attention of the Global Safety officers
• Requests follow-up information from authors, when necessary in regard to further handling of the received information within pharmacovigilance i.e. risk management
• Serves as medical mentor for Literature Reviewers of Contract Research Organization (CRO) for the accuracy of literature review result, case selection and correct documentation and provides expert guidance for the accurate medical assessment of literature publications to PV Case Processors
• Ensures compliance with QD/SOPs and health authority regulations by executing QC steps regarding the Literature review and process
• Performs ongoing quality checks of CRO literature review and literature case entry and provides feedback also for training purposes of the colleagues at the CRO
• Deploy processes related to the EMA Medical Literature Monitoring to avoid sending duplicate cases to the EMA
• Continued interaction with all PV Single Case Processing, PV Risk Management, outsourced CRO and Product Information Group to ensure high quality of literature review
• Responsible for continuous process improvement activities related to area of responsibility
• Responsible to maintain good documentation practice and be the Point of Contact in case of inspection/audit

Key working relationships

• This role will be the key contact point for countries and regions for all topics related to PV Literature surveillance
• This position requires multiple interfaces with partners and customers within and outside of the Company this includes Regulatory, TA team and PSR team
• Work closely with CHC PSR team members
• It requires experience in managing complex issues in a global environment

About You

• The person can be based anywhere in the world where CHC has a Legal Entity.

Education

• PharmD or Phd or Equivalent with 8 years of Pharmacovigilance experience with at least 4 years in PV Literature Surveillance experience

Required Knowledge And/or Experience

• Knowledge of pharmacovigilance processes including global and local regulatory requirements and rules
• Must have knowledge of the EMA Medical Literature Monitoring (MLM)regulations, ICH principles of SAE/AE reporting along with an understanding of global regulatory rules and regulations and knowledge of safety policies and procedures in the major countries
• Must have a good understanding of AE coding conventions (MedDRA)
• Ability to write/update/contribute to quality documents/job aids/WINs and developing training material to perform training to PV
• Ability to manage and lead transversal meetings and small to moderate size groups and take appropriate decisions
• Strong interpersonal skills and the ability to collaborate productively in an international and multi-cultural environment

Language skills

• Fluent spoken and written English

Key Dimensions

• Leadership, Teamwork and Management skills
• Good interpersonal and negotiator skills
• Strong decision-making skills

Play to Win Behaviours:

• Stretch
• Take action
• Act for patients & customers
• Think Sanofi first