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Medical Reviewer I

extra holidays

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

Poland

Offer summary

Qualifications:

Medically qualified as a physician, Experience in Pharmacovigilance preferred, Desirable experience in aggregate reports and signal detection.

Key responsabilities:

Review post-marketing Individual Case Safety Reports
Analyze serious adverse event reports
Perform literature screening for safety-related findings
Provide input for safety update reports
Engage in signal detection activities and reporting

ERGOMED Large https://www.ergomedcro.com/

1001 - 5000 Employees

See more ERGOMED offers

Job description

Company Description

We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. 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 has become one of the global leaders in its field. We cover all therapy areas including medical device.

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

Responsibilities include:

To review and approve post-marketing Individual Case Safety Reports (lCSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials 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 review 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
Reviewing database outputs
To review and provide input in Periodic Safety Update Reports
To review and provide input in Development Safety Update Reports
Participating in signal detection activities including meetings and writing signal detection reports
Proposing a course of action whenever a possible signal is identified

Qualifications

Medically qualified as a physician with demonstrated experience in Pharmacovigilance
Any experience in aggregate reports and signal detection is desirable
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!   