Senior Pharmacovigilance Physician I in Bucuresti

Job Description For the Client To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions. 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 provide input in Periodic Safety Update Reports, Development Safety Update Reports, 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 the preparation of responses to regulatory authority requests Signalling Reviewing line listings Participating in signal detection activities including meetings, writing signal detection reports if applicable if required, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation Evaluating and categorizing possible signals and proposing a course of action Supporting preparation and review of benefit-risk reports 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 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 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 cross-culturally and cross-functionally 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 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.