Job Opportunities at Sanofi

Job Purpose:

• To manufacture a good quality product according to the Batch Manufacturing Record
• To operate machinery in a pharmaceutical manufacturing environment, according to standard operating procedures and safety and health guidelines.

Key Accountabilities:

• Setting up and changing over the machines used in the manufacturing process according to the correct procedures, and with the specified standard times.
• Operating the machines according to the operating procedures.
• Cleaning the machines according to the cleaning procedures.
• Cleaning the manufacturing areas/rooms according to the cleaning procedures.
• Manufacturing he product according to the instructions on the Batch Manufacturing Record (BMR)
• Dispensing of raw materials in the required quantities, according to the correct procedure as per the BMR when required
• Performing all in process control checks as specified in the BMR.
• Performing any daily checks in the department as allocated, such as measuring of Pressure Differentials, cleaning of water points, daily checks of scales, etc, and completing the required logbooks.
• Working in a safe manner at all times and adhering to all safety procedures.
• Informing the Area Supervisor and Team Leader of all occurrences during the manufacture of the batch of product.
• Completing all documentation such as logbooks, BMR’s, Clearance labels, etc, used during the manufacture of a batch of product.
• Working according to c. GMP and maintaining the area of work in such a manner that it is ready for an audit at any time.
• Performing any other reasonable request for which training has been received.

ABOUT YOU:

Education:

• Grade 10

Knowledge and Experience:

• Good Manufacturing Practices (GMP) / Environmental Health and Safety (EHS)
• Operating machines in a pharmaceutical environment
• English written and verbal
• A sense of responsibility and urgency
• Effective time management
• Ability to work with accuracy
• Ability to perform problem solving in his area of responsibility.

PLAY TO WIN BEHAVIORS

• Push to go beyond the level we have operated until now: constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what won’t: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgment.
• Put the interest of the organization ahead of own: consider both short and long-term impact of decisions; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate level.
• Act in the interest of our patients and customers: actively engage with customers to know their current and future needs; brings an external perspective into decisions
• Take action and don’t wait to be told what to do
• take smart and informed best bets with the information at hand and anticipate the consequences of her/his actions; use personal judgement and others’ advice to make bold and impactful decisions which move us forward

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• 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

go to method of application »

About The Job
Our Team

• This position is responsible for supporting Consumer Healthcare Pharmacovigilance team with lifecycle support of PV Reporting and Analytics systems
• As a PV Reporting & Analytics lead, your responsibilities include managing hosting vendor, system functionality, user requirements and configuration specifications, system releases and service management tasks
• Provide system and administration support to business users within the Consumer Health PV organization including Consumer Healthcare PV Operations, PV Affiliates, PV Compliance, Safety Signal & Risk Management, Global Medical, Regulatory, Quality and other business functions
• This position is responsible for managing GxP validated PV Reporting & Analytics system and developing and maintenance of all Regulatory reports

Key results/accountabilities

• This position is Accountable for resolving and escalating incidents, managing user requests in collaboration with Digital teams and the hosting Vendor
• Initiate discussions with business stakeholders to understand reporting requirements, document user requirements and ensure these are included on the Backlog List and addressed in collaboration with Vendor & Digital teams
• Communicate effectively to all stakeholders, including content and plan of systems releases, issues, etc.
• Collect Business/Regulatory requirements, plan, design and develop reports and ensure the reports meets both Regulatory and GxP requirements
• Ensure training materials are updated as releases move through the development and deployment process. Facilitate support and training sessions for system users
• Maintain systems access and assessing any impact to systems security due to the introduction of new system features. Conduct regular access management reviews to remain in compliance with corporate security policies
• Provide Audit support by providing ad-hoc reports and lead or participate in system internal audits and/or external inspections as needed
• Support oversight of vendor assigned staff for PV Reporting system and monitor KPIs and assist with incidents and escalations as needed as part of governance structure

Key working relationships

• This role will be the key contact point for peers in CHC PV organization for all topics related to the usage of shared systems and databases, ensuring that the CHC PV needs are met
• This position requires multiple interfaces with partners and customers within and outside of the Company
• 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

• Degree in Science or Computer Science or Information Technology or relevant Academic qualification is desirable with at least 5 years' experience in GxP systems

Required Knowledge And/or Experience

• Experience in PV Databases like ARGUS/ARISG and Cognos Reports
• Experience in a PV reporting systems operations within safety/pharmacovigilance as business analyst, configuration manager or business relationship manager
• Experience with leading PV Reporting systems
• Experience and understanding of Pharmacovigilance process and regulations, ICH GCP and GxP regarding systems validation and documentation
• Knowledge of IT systems in the pharmaceutical industry with an emphasis on PV systems. Knowledge of validation processes
• Good knowledge of PL/SQL and MS Office
• Minimum 10 years of pharmaceutical industry experience with a focus on pharmacovigilance. Strong experience in IS and validation is required. Incumbent should have experience in Process Improvement practices

Language skills

• Fluent spoken and written English
• An Additional language is desirable

Key Dimensions

• 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

go to method of application »

Our Team

• This position is responsible for supporting Consumer Healthcare Pharmacovigilance team with lifecycle support of PV Database and it’s supporting systems
• As an Operations lead, responsibilities include managing PV Database hosting vendor, system functionality, user requirements and configuration specifications, system releases and service management tasks
• Provide system and administration support to business users within the Consumer Health PV organization including Consumer Healthcare PV Operations, PV Affiliates, PV Compliance, Safety Signal & Risk Management, Global Medical, Regulatory, Quality and other business functions
• This position is responsible for managing GxP validated systems including PV Database, Signal & Risk Management, Reporting system etc. and ensuring Agency Regulations are appropriately configured

Key results/accountabilities

• This position is Accountable for resolving and escalating incidents, managing user requests in collaboration with Digital teams and PV Database hosting Vendor
• Initiate discussions with business stakeholders to understand business requirements, document user requirements and ensure these are included on the Backlog List and addressed in collaboration with Vendor & Digital teams
• Communicate important messages relevant to all levels of stakeholders, including content and plan of systems releases, issues, etc.
• Plan for scheduled/ad-hoc releases by developing and execution of test scripts. Work in close collaboration with Vendor/Digital teams for the implementation of all releases in ensuring GxP validation requirements are met
• Ensure training materials are updated as releases move through the development and deployment process. Facilitate support and training sessions for system users
• Maintain systems access and assessing any impact to systems security due to the introduction of new system features. Conduct regular access management reviews to remain in compliance with corporate security policies
• Responsible for supporting Audit/Assessment/Inspection readiness and lead or participate in system internal audits and/or external inspections as needed
• Support oversight of vendor assigned staff for existing safety database during transition period, monitoring of KPIs, assist with incidents and escalations as needed as part of governance structure

Key working relationships

• This role will be the key contact point for peers in CHC PV organization for all topics related to the usage of shared systems and databases, ensuring that the CHC PV needs are met
• This position requires multiple interfaces with partners and customers within and outside of the Company
• 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

• Degree in Science or or relevant Academic qualification is desirable with 8 years experience in GxP systems preferably in PV databases

Required Knowledge And/or Experience

• Experience in PV Databases like ARGUS, ARISG, VAULT Safety etc.
• Experience in a systems operations support role within safety/pharmacovigilance as business analyst, configuration manager or business relationship manager
• Experience with leading safety systems
• Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GCP and GxP regarding systems validation and documentation
• Knowledge of IT systems in the pharmaceutical industry with an emphasis on PV systems. Knowledge of validation processes
• Good knowledge of PL/SQL and MS Office
• Minimum 8 years of pharmaceutical industry experience with a focus on pharmacovigilance. Strong experience in IS and validation is required. Incumbent should have experience in Process Improvement practices

Language skills

• Fluent spoken and written English
• An Additional language is desirable

Key Dimensions

• 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