PV Physician II

6 months ago

Pune, India PrimeVigilance Full time
Job Description

The Pharmacovigilance (PV) Physician II is responsible for medical review of ICSRs and literature review, writing signal detection reports, supporting writing and or reviewing of aggregate reports (DSURS, PSURS, PBRERs, PADERS).

• 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 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 reports

• 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

• Can be delegated to support signal detection activities upon acquiring sufficient experience

• Proposing a course of action whenever a new risk is identified


Qualifications

The PV Physician should be medically qualified as a physician with demonstarted experience in PharmacoVigilance and working in a clinical setting.

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    

Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application

 

  • Pv Physician Ii

    2 months 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...

  • Pv Physician Ii

    6 months ago

    Pune, Maharashtra, India PrimeVigilance Full time

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

  • Pv Physician Ii

    1 week ago

    Pune, Maharashtra, India PrimeVigilance Full time

    **Company Description** We 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,...

  • Senior PV Physician I

    2 months ago

    Pune, India PrimeVigilance Full time

    Job DescriptionFor the Client:To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) 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...

  • Associate Medical Director

    4 weeks ago

    Pune, India PrimeVigilance Full time

    Job DescriptionThe Associate Medical Director needs to work with the Head of Medical Operations/Medical Director on the following:• Assignment of the PV physicians to client projects• Ensuring adequate and appropriately qualified physician resources across client projects• Ensuring quality, compliance and efficiency for physician activities within a...

  • Pv Physician I

    6 months ago

    Pune, India PrimeVigilance Full time

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

  • Pharmacovigilance Scientist

    6 months ago

    Pune, India Fusion Market Research Full time

    Division Research and Development / Global Drug Development / Worldwide Patient Safety/Medical Safety Assessment (MSA) Functional Area Description The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including...

  • Pharmacovigilance Scientist

    6 months ago

    Pune, India Fusion Market Research Full time

    Sample responsibilities for this position include: Daily activities involve Have in-depth product knowledge, serve as product point of contact, and support Safety Management Team deliverables Partner with team members, stakeholders including Medical Safety Officer (MSOs), and a vendor Strategically plan and ensure timely, quality reports/safety analyses...

  • Pharmacovigilance Scientist

    6 months ago

    Pune, India Fusion Technology Solutions Full time

    Position Responsibilities General Product Support Supports Medical Safety Assessment Physician (MSAP) leading signal detection activities for a product's emerging safety profile. Prepare/write PV sections of aggregate safety documents (eg, DSUR, PBRER) and analyze data for the RSI section of the IB. Write and analyze data for ad hoc responses to health...

  • Systems Administrator Ii

    6 months ago

    Pune, Maharashtra, India FIS Global Full time

    **Position Type**: Full time **Type Of Hire**: Experienced (relevant combo of work and education) **Education Desired**: Bachelor of Information Technology **Travel Percentage**: 0% **3+ Yrs - Wintel System Admin (Azure, Citrix, M365, Intune, Windows Server, AD admin., VMWare admin., Exchange) for Bangalore location.** **About this team**: The Corporate...

  • Electrical Engineer II

    6 months ago

    pune, India Johnson Controls Full time

    What you will do In this role, you will be part of product development team to manage & deliver new product functionalities, modify existing product’s functionalities or improve product functionalities as required. Will work within Embedded HW development group in the design, development and test of HW product development for Fire detection...

  • Electrical Engineer II

    6 months ago

    Pune, India Johnson Controls Full time

    What you will do In this role, you will be part of product development team to manage & deliver new product functionalities, modify existing product’s functionalities or improve product functionalities as required. Will work within Embedded HW development group in the design, development and test of HW product development for Fire detection systems. ...

  • Hardware Design Engineer II

    3 days ago

    Pune, Maharashtra, India Johnson Controls Full time

    What you will doIn this role, you will be part of product development team to manage & deliver new product functionalities, modify existing product’s functionalities or improve product functionalities as required.The Sr. Engineer Hardware will work closely with HW technical lead for the Embedded HW development group in the design, development and test of...

  • Johnson Controls | Hardware Design Engineer II | pune

    4 days ago

    pune, India Johnson Controls Full time

    What you will doIn this role, you will be part of product development team to manage & deliver new product functionalities, modify existing product’s functionalities or improve product functionalities as required.The Sr. Engineer Hardware will work closely with HW technical lead for the Embedded HW development group in the design, development and test of...

  • Fired Equipment Engineer

    4 weeks ago

    pune, India NOVARGI Full time

    NOVARGI Indian branch, an Indian established company belonging to the International Group NOVARGI, is currently seeking a FIRED HEATER Engineer to join the Indian team based in PUNE. NOVARGI Group, as a highly specialized Process Package and Plant Contractor for the Energy Sector, we contribute to better tomorrow with our process and engineering solutions....

  • Fired Equipment Engineer

    4 weeks ago

    pune, India NOVARGI Full time

    NOVARGI Indian branch, an Indian established company belonging to the International Group NOVARGI, is currently seeking aFIRED HEATER Engineerto join the Indian team based in PUNE.NOVARGI Group, as a highly specialized Process Package and Plant Contractor for the Energy Sector, we contribute to better tomorrow with our process and engineering solutions. The...

  • Fired Equipment Engineer

    1 month ago

    pune, India NOVARGI Full time

    NOVARGI Indian branch, an Indian established company belonging to the International Group NOVARGI, is currently seeking a FIRED HEATER Engineer to join the Indian team based in PUNE.NOVARGI Group, as a highly specialized Process Package and Plant Contractor for the Energy Sector, we contribute to better tomorrow with our process and engineering solutions....

  • Fired Equipment Engineer

    1 month ago

    Pune, India NOVARGI Full time

    NOVARGI Indian branch, an Indian established company belonging to the International Group NOVARGI, is currently seeking a FIRED HEATER Engineer to join the Indian team based in PUNE.NOVARGI Group, as a highly specialized Process Package and Plant Contractor for the Energy Sector, we contribute to better tomorrow with our process and engineering solutions....

  • Fired equipment engineer

    1 month ago

    Pune, India NOVARGI Full time

    NOVARGI Indian branch, an Indian established company belonging to the International Group NOVARGI, is currently seeking a FIRED HEATER Engineer to join the Indian team based in PUNE.NOVARGI Group, as a highly specialized Process Package and Plant Contractor for the Energy Sector, we contribute to better tomorrow with our process and engineering solutions....

  • Fired Equipment Engineer

    1 month ago

    Pune, India NOVARGI Full time

    NOVARGI Indian branch, an Indian established company belonging to the International Group NOVARGI, is currently seeking a FIRED HEATER Engineer to join the Indian team based in PUNE.NOVARGI Group, as a highly specialized Process Package and Plant Contractor for the Energy Sector, we contribute to better tomorrow with our process and engineering solutions....