Senior PV Physician I
Senior PV Physician I
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Job Description
The Senior Pharmacovigilance (PV) Physician I is responsible for medical review of ICSRs writing and/or reviewing signal detection reports writing and or reviewing aggregate reports (DSURS PSURS PBRERs. PADERS) reviewing risk management reports (RMPs) and mentoring junior PV Physicians.
The Senior PV Physician I is also expected to support the QPPV in medical aspects and safety issues as may be required by Company or Client.
To review and approve postmarketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical/causality assessment. Review includes coding assessment of seriousness listedness/expectedness and Company causality as well as writing of Company comment followup questions and Analysis of Similar Events when required. Including completion of all requiredsupporting documentation such as trackers.
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 approve 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/to lead the preparation of responses to regulatory authority requests
To review and provide input in Periodic Safety Update Reports Development Safety Update Reports ACOs or Annual Safety Reports.
To act as Company Lead in a specific pharmacovigilance area requiring medical input (e.g. for preparation of reference safety information Company Core Data Sheet)
Participating in signal detection activities including meetings reviewing of signal detection reports and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation
To provide training and mentoring of junior PV Physicians
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 crossculturally and crossfunctionally and value the importance of teamwork
- Communication skills
- Presentation skills
- English 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 humancentric 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 patients lives. We look forward to welcoming your application.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
