Principal PV Training Specialist

The Principal PV Training Specialist is responsible for developing and providing training for PV procedures, systems, and practices within global PV, for stakeholder functions, and across local operating companies.

Primary responsibilities include:Lead training gap analyses and implement training to fill gaps.Partner with key stakeholders in PV and QA to support the development and implementation of effective PV training compliance.Perform root cause analysis and implementation of process improvement strategy related to PV training scope to ensure alignment with GPV business objectives.Serve as departmental trainer and provide training in all relevant areas, including the safety database Argus Review compliance and training procedures for local and regional offices in support of global alignment activities.Prepare data, interpret and perform impact analysis regarding metrics for PV training compliance.Manage the investigation of non-compliance and implementation of corrective measures where required in the scope of PV training activities.Develop and distribute regular reports regarding training compliance activities to key stakeholders.Author and review quality documents supporting training processes.Perform impact analysis for PV compliance strategies and working practices, including input into safety exchange agreements, CRO oversight, SOPs, and other pertinent PV processes.Support global efforts to ensure PV regulatory inspection or internal audit readiness for dedicated PV or GCP inspections/audit.Develop and oversee training matrixes for the PV function.Responsible for management of PV training schedule.Serve as the contact point for PV training needs.Liaise with QA Documentation and Training Department as requiredEscalate issues/problems to management as needed. Perform other tasks as required to assist in departmental activities. The Principal PV Training Specialist is responsible for developing and providing training for PV procedures, systems, and practices within global PV, for stakeholder functions, and across local operating companies.

Primary responsibilities include:Lead training gap analyses and implement training to fill gaps.Partner with key stakeholders in PV and QA to support the development and implementation of effective PV training compliance.Perform root cause analysis and implementation of process improvement strategy related to PV training scope to ensure alignment with GPV business objectives.Serve as departmental trainer and provide training in all relevant areas, including the safety database Argus Review compliance and training procedures for local and regional offices in support of global alignment activities.Prepare data, interpret and perform impact analysis regarding metrics for PV training compliance.Manage the investigation of non-compliance and implementation of corrective measures where required in the scope of PV training activities.Develop and distribute regular reports regarding training compliance activities to key stakeholders.Author and review quality documents supporting training processes.Perform impact analysis for PV compliance strategies and working practices, including input into safety exchange agreements, CRO oversight, SOPs, and other pertinent PV processes.Support global efforts to ensure PV regulatory inspection or internal audit readiness for dedicated PV or GCP inspections/audit.Develop and oversee training matrixes for the PV function.Responsible for management of PV training schedule.Serve as the contact point for PV training needs.Liaise with QA Documentation and Training Department as requiredEscalate issues/problems to management as needed. Perform other tasks as required to assist in departmental activities. Education, Experience and Qualifications:

• Bachelors of Science Degree preferred in science-related or technical field Life science graduate, pharmacy, nursing or other healthcare qualification• 5 years of work experience in pharmacovigilance, including 2 years’ experience in a global setting• 2 years’ experience in training-related fields and technical writing• 2 years’ experience working within a pharmacovigilance system• Knowledge of FDA/EU regulations and ICH guidelines for GXP or devices• Proven experience in designing and delivering Global PV training, ideally remotely• Advanced Microsoft Office skills

Skills and Competencies:

• Requires strong attention to detail and is able to set priorities, schedule and meet deadlines• Ability to work independently, take initiative and complete tasks in accordance with direction and/or timelines• Excellent interpersonal, communication, analytical and organizational skills• A confident yet approachable communication style• Working knowledge of FDA and EU regulations and regulatory reporting requirements related to safety• Proficient knowledge of drug safety databases• Proficient in adverse event case management• Sound knowledge of MedDRA dictionary• Organization skills, including attention to detail and multitasking• Management skills, including time management and issue management

The positioncan be home based anywhere in EU or US.

How to apply? Please submit your CV in English.#LI-TK1Education, Experience and Qualifications:

• Bachelors of Science Degree preferred in science-related or technical field Life science graduate, pharmacy, nursing or other healthcare qualification• 5 years of work experience in pharmacovigilance, including 2 years’ experience in a global setting• 2 years’ experience in training-related fields and technical writing• 2 years’ experience working within a pharmacovigilance system• Knowledge of FDA/EU regulations and ICH guidelines for GXP or devices• Proven experience in designing and delivering Global PV training, ideally remotely• Advanced Microsoft Office skills

Skills and Competencies:

• Requires strong attention to detail and is able to set priorities, schedule and meet deadlines• Ability to work independently, take initiative and complete tasks in accordance with direction and/or timelines• Excellent interpersonal, communication, analytical and organizational skills• A confident yet approachable communication style• Working knowledge of FDA and EU regulations and regulatory reporting requirements related to safety• Proficient knowledge of drug safety databases• Proficient in adverse event case management• Sound knowledge of MedDRA dictionary• Organization skills, including attention to detail and multitasking• Management skills, including time management and issue management

The positioncan be home based anywhere in EU or US.

How to apply? Please submit your CV in English.#LI-TK1Belgium, Romania, United States, Portugal, Czech Republic, Bulgaria, Spain, Ireland, Slovakia, Netherlands, United Kingdom, Germany, Croatia, France, Austria, Italy, Serbia, Poland, GreeceBelgium, Romania, United States, Portugal, Czech Republic, Bulgaria, Spain, Ireland, Slovakia, Netherlands, United Kingdom, Germany, Croatia, France, Austria, Italy, Serbia, Poland, Greece