Pharmacovigilance Physician Ii
1 dia atrás
Job Description The Senior Pharmacovigilance (PV) Physician II is responsible for medical review of ICSRs, writing and reviewing signal detection reports, writing and/or reviewing aggregate reports (DSURS, PSURS/PBRERs/PADERS, ACOs, responses to regulatory authority requests), writing and/or reviewing riskmanagement reports (RMPs) and mentoring junior PV Physicians.
The Senior PV Physician II 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 post-marketing 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, follow-up 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 product's life cycle.
Serves on Client's advisory and scientific committees.
Signalling Reviewing line listings 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 benefit-risk reports Supporting PV Project Managers in the planning of signalling schedule and resources Supporting PV Project Managers in the preparation of project-specific 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 with demonstrated experience in PharmacoVigilance and working in a clinical setting.
Endocrinology experience is required.
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 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
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