Medical Reviewer I

4 days ago

Pune Maharashtra, India 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.

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
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships

  • Medical Reviewer I

    1 week ago

    Pune, Maharashtra, India PrimeVigilance Full time

    Company DescriptionWe are PrimeVigilance part of Ergomed PLC 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...

  • Medical And Scientific Reviewer

    4 weeks ago

    Pune, Maharashtra, India EVERSANA Full time

    Company Description At EVERSANA we are proud to be certified as a Great Place to Work across the globe We re fueled by our vision to create a healthier world How Our global team of more than 7 000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry We are grounded in our cultural...

  • Medical Reviewer

    2 days ago

    Pune, India Principal Global Services Full time

    **Responsibilities**: **Years of Experience: 2 to 5 years relevant experience** **Role Description**: - Support sales goals by reviewing required information on a timely basis consistent with provided guidance - Support profitability goals by summarizing medical information accurately **Reporting relationship**: This role will report to Operations -...

  • Medical Writer I

    2 days ago

    Pune, Maharashtra, India Syneos - Clinical and Corporate - Prod Full time

    **Description** Medical Writer I (CTT) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the...

  • Medical Writer I

    3 weeks ago

    Pune, Maharashtra, India inVentiv Health Clinical SRE, LLC Full time

    Job DescriptionDescriptionMedical Writer I (CTT)Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to...

  • Medical Writer I

    3 hours ago

    Pune, Maharashtra, India Syneos - Clinical and Corporate - Prod Full time

    **Description** Medical Writer I (CTD/CTT) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to...

  • Medical Documentation Reviewer

    2 weeks ago

    Erandwane, Pune, Maharashtra, India Planetary Talent Full time

    _**NOTE-This role is an office-based role in Pune**_ **Client Profile** A leading AI platform designed for law firms, combining advanced technology with deep legal expertise to deliver impactful data-driven outcomes. The platform offers human-level accuracy in analyzing complex legal data, enabling firms to quickly access critical insights when needed...

  • Associate Medical Reviewer

    2 weeks ago

    Pune, Maharashtra, India Principal Global Services Full time

    **Responsibilities**: Qualifications: - Bachelor of Dental Surgery (BDS) or Master in Dental Surgery (MDS). - Minimum of 2-4 years’ experience in medical/dental claims processing, and/or industry courses (i.e., LOMA). Prior claim paying, and/or medical/dental industry experience preferred. - Proficient in MS Office, written and verbal communication...

  • Medical Writing Ii

    1 week ago

    Pune, Maharashtra, India Syneos - Clinical and Corporate - Prod Full time

    **Description** Medical Writing II (CSR Narrative, QC review) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer...

  • Medical Content and Regulatory Review Coordinator

    2 weeks ago

    Pune, Maharashtra, India beBeeRegulatory Full time US$ 90,000 - US$ 1,20,000

    Job Title: Medical Content and Regulatory Review CoordinatorWe are seeking a highly skilled Medical Content and Regulatory Review Coordinator to join our team. The ideal candidate will have a strong background in medical content and regulatory review, with excellent communication and project management skills.Job Description:Oversee the end-to-end review...