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1 Vacancy
For our clients
To review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. Review includes coding assessment of seriousness listedness/expectedness and company causality as well as writing of company comments follow-up questions and analysis of similar events when required including the completion of all required supporting documentation such as trackers.
To 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 reports
To review 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
Reviewing database outputs
Can be delegated to support signal detection activities upon acquiring sufficient experience
Proposing a course of action whenever a new risk is identified
For the Company
To contribute to the preparation of PV procedures
The PV Physician will support the Project Manager as well as the QPPV on a day to day basis as needed
Qualifications :
The PV Physician should be medically qualified as a physician.
1 year of experience in pharmacovigilance is required (Or 1 year of experience in clinical medicine)
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.
Additional Information :
We offer excellent chances to progress and develop. We work on a global basis on interesting projects within rare diseases oncology and neurology. This is an ideal position to continue developing a career in clinical drug development.
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 Ergomed is a great company to join!
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
We look forward to welcoming your application.
#LI Remote
Remote Work :
Yes
Employment Type :
Full-time
Remote