Medical Reviewer II

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
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.
#LI Remote

PrimeVigilance