Senior Pharmacovigilance Physician I
Senior Pharmacovigilance 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.
For the 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 required supporting documentation such as trackers.
To complete the adverse event tracker for all ICSRs reports
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
Can act as EEA QPPV and/or Deputy for up to 2 clients if required.
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)
Actively participate in the Drug Safety Review Committee signal detection and risk evaluation process for Client company medicinal products in the products life cycle. Serves on Clients advisory and scientific committees.
Signalling
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
Evaluating and categorizing possible signals
Proposing a course of action whenever a possible signal is identified
Supporting preparation and review of benefitrisk reports
Supporting PV Project Managers in the planning of signalling schedule and resources
Supporting PV Project Managers in the preparation of projectspecific working instructions regarding signalling
Overseeing the quality of signal detection activities and providing quality and compliance metrics to the Quality Department
For the Company
To support the preparation of PV procedures
To provide training and mentoring of junior PV Physicians
To provide medical advice and input to project teams on daily basis
Training mentoring and managing junior PV Physicians
Continuously working on the development of the procedures on the company level
Preparing or contributing to the preparation of signalling related company procedures
The Senior PV Physician will support the Director of Projects as well as the QPPV on a day to day basis as needed
Supporting the Medical Director in training and mentoring on signalling activities
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)
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
