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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

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What You Should Know About Medical Reviewer II, Ergomed

Join PrimeVigilance as a Medical Reviewer II in Bucharest, Romania, where you'll play a vital role in ensuring the safety and efficacy of medical therapies. In this dynamic position, you will be responsible for reviewing Individual Case Safety Reports (ICSRs), assessing Serious Adverse Events (SAEs), and writing comprehensive signal detection reports. Working closely with our dedicated teams, you'll help write and review aggregate reports like Development Safety Update Reports (DSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs). At PrimeVigilance, we pride ourselves on fostering a collaborative and supportive atmosphere, emphasizing continuous training and development for our team members. Your expertise in pharmacovigilance will be paramount as you collaborate with cross-functional teams to prepare responses to regulatory inquiries and craft Risk Management Plans. With a focus on work-life balance, we have cultivated an environment where our employees can thrive and contribute to transforming lives positively. If you're a medically qualified physician with a passion for patient safety and a knack for signal detection activities, PrimeVigilance is the perfect place for you to advance your career and make a real difference in the pharmaceutical landscape.

Frequently Asked Questions (FAQs) for Medical Reviewer II Role at Ergomed
What are the responsibilities of a Medical Reviewer II at PrimeVigilance?

As a Medical Reviewer II at PrimeVigilance, your main responsibilities include reviewing ICSR reports and SAEs, writing and reviewing aggregate safety reports, and contributing to signal detection activities. You'll also have the opportunity to evaluate safety signals and support the Qualified Person for Pharmacovigilance in their regulatory responsibilities.

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What qualifications do I need to apply for the Medical Reviewer II position at PrimeVigilance?

To qualify for the Medical Reviewer II role at PrimeVigilance, you need to be a medically qualified physician with previous experience in pharmacovigilance. Expertise in reviewing aggregate reports like PBRERs and DSURs, along with excellent interpersonal and communication skills, are essential for success in this position.

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What is the work environment like for a Medical Reviewer II at PrimeVigilance?

The work environment at PrimeVigilance for a Medical Reviewer II is friendly and supportive, emphasizing teamwork and collaboration. We are committed to creating a human-centric workplace where diversity and inclusion are prioritized, enabling our employees to feel valued and motivated.

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How does PrimeVigilance support career development for Medical Reviewer IIs?

PrimeVigilance invests in the career development of Medical Reviewer IIs by offering training and mentorship opportunities. We focus on personal and professional growth, ensuring our staff is well-prepared to tackle challenges and advance in their careers.

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What skills are essential for a Medical Reviewer II to succeed at PrimeVigilance?

To succeed as a Medical Reviewer II at PrimeVigilance, essential skills include a strong understanding of pharmacovigilance procedures, excellent organizational and prioritization abilities, strong communication skills, and proficiency in MS Office. Effective cross-cultural collaboration and teamwork are also critical.

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What type of impact can a Medical Reviewer II have at PrimeVigilance?

A Medical Reviewer II at PrimeVigilance can significantly impact patient safety by ensuring accurate reporting and evaluation of adverse events. Your expertise will contribute to the development of effective Risk Management Plans and help foster a culture of safety within our pharmaceutical and biotechnology partners.

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Are there opportunities for remote work as a Medical Reviewer II at PrimeVigilance?

Yes, at PrimeVigilance, we offer remote work opportunities for Medical Reviewer IIs. Our flexible working arrangements aim to support work-life balance and allow you to collaborate effectively with colleagues from around the globe.

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Common Interview Questions for Medical Reviewer II
What is your experience with pharmacovigilance and how will it benefit your work as a Medical Reviewer II?

Share specific examples from your previous roles where your pharmacovigilance expertise led to successful safety assessments or reports. Highlight your experience with ICSR reviews and any relevant aggregate reporting to demonstrate your suitability for the role.

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How do you prioritize tasks when dealing with multiple reports as a Medical Reviewer II?

Talk about your approach to task prioritization, such as using a checklist or software tools. Emphasize how you stay organized under pressure and manage deadlines effectively to ensure thorough reviews without compromising quality.

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Describe your experience with signal detection activities.

Provide examples of your involvement in signal detection, including techniques you've used and how your contributions influenced medical safety decisions. Discuss any challenges faced and how you overcame them, showcasing your analytical skills.

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What role does teamwork play in your effectiveness as a Medical Reviewer II?

Discuss the importance of collaboration in ensuring accurate reviews and addressing safety signals. Share instances where teamwork led to improved patient safety outcomes and how you communicate well with cross-functional teams.

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How do you stay updated on regulations and best practices in pharmacovigilance?

Mention specific resources such as professional organizations, journals, and courses you engage with. Highlight your commitment to lifelong learning and how you apply new knowledge to your work at PrimeVigilance.

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Can you give an example of a time you had to advocate for patient safety?

Narrate a situation where you identified a potential risk and took steps to address it within your organization. Explain the actions you took and the outcome to demonstrate your dedication to patient safety.

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What challenges do you foresee in the role of Medical Reviewer II, and how would you address them?

Recognize potential challenges like regulatory changes or workload spikes. Explain your strategies for addressing these challenges, such as maintaining open communication with your team and managing your time efficiently.

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How would you approach writing a signal detection report?

Describe your methodology for writing signal detection reports, stressing the importance of clarity, comprehensiveness, and adherence to regulatory requirements. Share any tools or formats you find effective in structuring these reports.

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What are your strengths that make you a good fit for the Medical Reviewer II position?

Reflect on your technical skills in pharmacovigilance, such as review expertise, as well as soft skills like communication and teamwork that align with PrimeVigilance's values of collaboration and integrity.

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How do you ensure accuracy in risk assessments and reports?

Discuss your approach to meticulous review processes, such as double-checking information and seeking input from colleagues when necessary. Highlight your prioritization of accuracy to safeguard patient safety.

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Founded in 1997, Erogmed is a global provider of clinical trial planning, management, and monitoring; and drug safety and medical information services. The company offers clinical development, trial management, and pharmacovigilance services for p...

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Full-time, remote
DATE POSTED
November 26, 2024

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