PV Physician I/II (Japanese)
Company Description
We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical devices.
We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Job Description
For the Client:
To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions.
To act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues
To review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy
To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
To cooperate in the preparation of and provide input in Risk Management Plans
Supporting the preparation of responses to regulatory authority requests
Signalling
Reviewing line listings
Participating in signal detection activities including meetings, writing signal detection reports if applicable if required, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation
Evaluating and categorizing possible signals and proposing a course of action
Supporting preparation and review of benefit-risk reports
Qualifications
The PV Physician should be medically qualified as a physician
Previous experience in pharmacovigilance
Ability to review different aggregate report types including PBRERs and DSURs
Expertise in signal detection activities is essential
Excellent interpersonal skills
Ability to plan, organise, prioritise and execute multiple tasks
Ability to work effectively cross-culturally and cross-functionally and value the importance of teamwork
Communication skills
Presentation skills
English - advanced (spoken, written)
Japanese - advanced (spoken, written)
Advanced literacy (MS Office)
Additional Information
Why PrimeVigilance
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly, supportive working environment
Opportunity to work with colleagues based all over the world, with English as the company language
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.
Department: PV Medical Group
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We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover all therapy areas including medical devices.
We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Job Description
For the Client:
To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions.
To act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues
To review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy
To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings
To cooperate in the preparation of and provide input in Risk Management Plans
Supporting the preparation of responses to regulatory authority requests
Signalling
Reviewing line listings
Participating in signal detection activities including meetings, writing signal detection reports if applicable if required, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation
Evaluating and categorizing possible signals and proposing a course of action
Supporting preparation and review of benefit-risk reports
Qualifications
The PV Physician should be medically qualified as a physician
Previous experience in pharmacovigilance
Ability to review different aggregate report types including PBRERs and DSURs
Expertise in signal detection activities is essential
Excellent interpersonal skills
Ability to plan, organise, prioritise and execute multiple tasks
Ability to work effectively cross-culturally and cross-functionally and value the importance of teamwork
Communication skills
Presentation skills
English - advanced (spoken, written)
Japanese - advanced (spoken, written)
Advanced literacy (MS Office)
Additional Information
Why PrimeVigilance
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly, supportive working environment
Opportunity to work with colleagues based all over the world, with English as the company language
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.
Department: PV Medical Group
Apply tot his job
Apply To this Job