MEDICAL REVIEWER II
Descrição da oferta de emprego
We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within.
Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields.
We cover all therapy areas including medical devices.
We love investing in our staff by providing an excellent training and development platform.
We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
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 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.
I'm interested I'm interested Privacy Policy
Detalhes da oferta
- Indeterminado
- Em todo Portugal
- Indeterminado - Indeterminado
- 31/10/2024
- 29/01/2025
Are you a dedicated nurse passionate about orthopaedic care, seeking an opportunity to expand your knowledge and skills within a top of the art dedicated hospital? have you imagined being part of a dynamic team, collaborating with top-tier medical experts in a state-of-the-art medical facility where......
✓private medical insurance will be provided (after successfully completing the probationary period)... requisitos do trabalho excellent communication skills and ability to work well in a team... ✓customer satisfaction orientation and proactivity... ✓team building activities organized by cluster and/or......
✓private medical insurance will be provided (after successfully completing the probationary period)... requisitos do trabalho excellent communication skills and ability to work well in a team... ✓customer satisfaction orientation and proactivity... ✓team building activities organized by cluster and/or......
Private medical insurance will be provided (after completion of the probationary period)... salary paid in twelve or fourteen months... 2023 salary: up to 1,200€ monthly gross (excluding performance bonus and/or other benefits)... ambitious to engage with other team members and share experiences......
Private medical insurance will be provided (after successful completion of probationary period)... process and record customer and internal requests, orders, tickets, etc... team building activities organized by cluster and/or its team members... maintain a respectful tone in all communications, both......
Empresa de construção civil, disaglima lda, com 20 anos no mercado da construção civil, nacional e internacional, pretende recrutar para obras em frança – paris: - trolha / pedreiro i e ii empresa garante estadia, alimentação e viagens a portugal salário atrativo entrada imediata cartão de cidadão português......
Want to help write healthcare history? the cambridge biomedical campus, the largest medical research and health sciences campus in europe, is also here for you... as you can see, there's a lot for you to do here... still at number 5, no point asking where you see yourself in 5 years’ time, one thing......
Medical degrees also accepted... • monitor and record residents' health status and needs... • support residents with daily living activities and promote their independence... • minimum 3 years of professional nursing experience for candidates without a diploma... about the jobtype of position: full-time......
Working time frames: monday – saturday 08:00 – 18:00 (40h per week, 5 days/week, 8h/day) with sundays off full time fixed term 1-year employment contract with extension possibility (according to the portuguese law) training is provided at the beginning of the work we offer office based work system......
Public holidays• complete online hiring process regulated & we send the equipment to your home!• a bring a friend program with attractive incentives• private health insurance from day 1• benefit from our modern amenities, many discounts in local businesses, free medical appointments at the office, sports......