Scientist - Surveillance and Risk Management
To see similar active jobs please follow this link: Remote Consulting jobs
Location: US– Homebased
Schedule: Permanent- FTE
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Scientist, Surveillance and Risk Management on a permanent basis, while working on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device, and consumer health companies.
Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!
Main Job Tasks and Responsibilities:
The incumbent has responsibility for the oversight and management of AE/PQC reporting to ensure compliance with related policies and procedures.
Provides Client with US commercial Operating Company contract review to ensure accuracy of the PSMF Annex B
Ensures audit and inspection readiness by monitoring compliance with policies and procedures related to Pharmacovigilance requirements and assists with the remediation of potential compliance gaps.
Develops and maintains working knowledge of all local PV and PQC procedural documents relevant to their role.
Demonstrates understanding and supports standard PV and PQC processes as described in contracts (e.g., internal collaboration, co-licensing agreements)
Assesses compliance of AE/PQC reporting to related policies and procedures, initiates corrective action, and documents root cause and actions taken.
Evaluates Client with US commercial Operating Company contracts to ensure compliance to PSMF Annex B requirements and remediates as necessary
Identifies and ensures timely transfer of complaints to respective companies (e.g., ex-US Client Pharma, MAcWeb)
Responsible for confirmation and review of entry of related research activities in the company repository.
Provides compliance metrics deck for inclusion in the US Pharma LSO Monthly Metrics and escalates any trends or issues to management
Assesses vendor AE/PQC logs for completeness and accuracy
Participate in safety compliance initiatives/projects as assigned by USCPvO Management.
Develops reports to support tracking and trending of AE/PQC information.
Supports Quality Event management by providing related documentation.
Collates and provides updates to the PSMF Annex A.
Drafts/update procedural documents, training content and reference documents as necessary
Provide mentoring and coaching for less experienced team members in the management of safety information.
Education and Experience:
3 years of pharmaceutical experience with related functions.
Prior experience in a safety compliance role preferred (i.e. - prior experience with regulatory mandated processes for handling adverse events and product quality complaints. Experience interfacing with auditing and compliance organization
Understanding of medical/pharmacology/nursing terminology
Knowledge of Clients Scientific Affairs-supported products preferred.
Knowledge of U.S. regulations surrounding adverse event/product quality complaint reporting.
Planning, organizational and interpersonal skills required.
Knowledge of MS Excel required; familiarity with Salesforce.com platform preferred.
Our Benefits:
Country specific benefits.
Excellent work-life balance
Dedicated Line Manager
Monthly meetings with line manager
Full performance and development process with end of year reviews
Team events and end of year party
Career opportunities within in ClinChoice, locally and globally
Employee satisfaction survey - your feedback is important for continuous improvement.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
About the job
Scientist - Surveillance and Risk Management
To see similar active jobs please follow this link: Remote Consulting jobs
Location: US– Homebased
Schedule: Permanent- FTE
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Scientist, Surveillance and Risk Management on a permanent basis, while working on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device, and consumer health companies.
Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!
Main Job Tasks and Responsibilities:
The incumbent has responsibility for the oversight and management of AE/PQC reporting to ensure compliance with related policies and procedures.
Provides Client with US commercial Operating Company contract review to ensure accuracy of the PSMF Annex B
Ensures audit and inspection readiness by monitoring compliance with policies and procedures related to Pharmacovigilance requirements and assists with the remediation of potential compliance gaps.
Develops and maintains working knowledge of all local PV and PQC procedural documents relevant to their role.
Demonstrates understanding and supports standard PV and PQC processes as described in contracts (e.g., internal collaboration, co-licensing agreements)
Assesses compliance of AE/PQC reporting to related policies and procedures, initiates corrective action, and documents root cause and actions taken.
Evaluates Client with US commercial Operating Company contracts to ensure compliance to PSMF Annex B requirements and remediates as necessary
Identifies and ensures timely transfer of complaints to respective companies (e.g., ex-US Client Pharma, MAcWeb)
Responsible for confirmation and review of entry of related research activities in the company repository.
Provides compliance metrics deck for inclusion in the US Pharma LSO Monthly Metrics and escalates any trends or issues to management
Assesses vendor AE/PQC logs for completeness and accuracy
Participate in safety compliance initiatives/projects as assigned by USCPvO Management.
Develops reports to support tracking and trending of AE/PQC information.
Supports Quality Event management by providing related documentation.
Collates and provides updates to the PSMF Annex A.
Drafts/update procedural documents, training content and reference documents as necessary
Provide mentoring and coaching for less experienced team members in the management of safety information.
Education and Experience:
3 years of pharmaceutical experience with related functions.
Prior experience in a safety compliance role preferred (i.e. - prior experience with regulatory mandated processes for handling adverse events and product quality complaints. Experience interfacing with auditing and compliance organization
Understanding of medical/pharmacology/nursing terminology
Knowledge of Clients Scientific Affairs-supported products preferred.
Knowledge of U.S. regulations surrounding adverse event/product quality complaint reporting.
Planning, organizational and interpersonal skills required.
Knowledge of MS Excel required; familiarity with Salesforce.com platform preferred.
Our Benefits:
Country specific benefits.
Excellent work-life balance
Dedicated Line Manager
Monthly meetings with line manager
Full performance and development process with end of year reviews
Team events and end of year party
Career opportunities within in ClinChoice, locally and globally
Employee satisfaction survey - your feedback is important for continuous improvement.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.