Medical Reviewer Ii

2 weeks ago

Mississauga, Canada PrimeVigilance Full time

**Company Description**
We are PrimeVigilance (part of Ergomed Group), 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.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

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.
**Qualifications**
For the Client (May include but is not limited to the following):

- 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
- Evaluating and categorizing possible signals
- Proposing a course of action whenever a possible signal is identified
- For the Company (This may include but is not limited to):

- Writing PV Procedures
- Mentoring less experienced Physicians

Physician Line Manager (as applicable):

- Distribution of tasks performed by physicians within designated team, as well as solving problems related to it on a daily basis - taking into account the quality of the work performed, respecting all relevant laws and procedures, as well as time limits - Ensuring stimulating work atmosphere within the team
- Developing and maintaining good relationship with clients - Represent main contact person for responding to all medical questions from the client
- Inform Medical Director about productivity and quality metrics of individual medics within medical team - Mentoring and coaching of staff within the team.
- Develop team development strategy and monitor progress through quality and performance reports
- Cooperate with other Line Managers and Medical Director to continuously improve work processes
- Providing support to Company development and, if necessary, assist in contract drafting and attending meetings with potential client meetings as well as pre-engagement audits

**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

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