PV Physician I
PV Physician I
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Salary Not Disclosed
1 Vacancy
Job Description
The Pharmacovigilance (PV) Physician II is responsible for medical review of ICSRs and literature review writing signal detection reports supporting writing and or reviewing of aggregate reports (DSURS PSURS PBRERs PADERS).
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 comment follow-up questions and Analysis of Similar Events when required. Including 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
Qualifications :
The PV Physician should be medically qualified as a physician with demonstarted experience in PharmacoVigilance and working in a clinical setting.
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
Additional Information :
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 companylanguage
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 patients lives. We look forward to welcoming your application!
Remote Work :
Yes
Employment Type :
Full-time
Employment Type
Remote
