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Medical Reviewer II

extra holidays

Remote:

Full Remote

Experience:

Mid-level (2-5 years)

Work from:

Poland

Offer summary

Qualifications:

Medically qualified as a physician, Previous experience in pharmacovigilance, Expertise in signal detection activities, Advanced proficiency in MS Office.

Key responsabilities:

Review post-marketing Individual Case Safety Reports (ICSRs)
Write and review aggregate reports as required

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

1001 - 5000 Employees

See all jobs

Job description

Company Description

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially 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 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

The Medical Reviewer II is responsible for medical review of lCSRs and literature review, writing signal detection reports, supporting writing and or reviewing of aggregate reports (DSURS, PSURS/PBRERs/PADERS) as required by the Company or Client.

For the Client:

To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs) 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 to 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 to 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

For the Company

Writing PV Procedures
Mentoring less experienced Physicians

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

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!