PV Associate

2 weeks ago

pune, India Ergomed Full time US$ 40,000 - US$ 80,000 per year
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. 

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

*Please only apply if you are either currently based in Pune or willing to relocate to Pune. If you have taken assessments or interviewed in the last 6 months, unfortunately we cannot reconsider you at this time.

Job Description

Responsibilities include:  

  • Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines, focusing on triage, data entry, quality review and submissions workflow steps. 
  • Reconciliation activities for all types of received reports 
  • Works under supervision and mentoring of more experienced colleague 
Qualifications
  • Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing    
  • Must have previous experience in Data Entry or QC
  • Demonstrated full start to finish case processing experience (2-3 years experience)
  • ARGUS/ LSMV/ ArisG experience required  
  • Time and issue management, delegation, organization and multitasking skills with good attention to detail   
  • Strong interpersonal and communication skills   
  • Must be able to work hybrid in Pune office
  • Advanced English skills, both verbal and written, at least C1  
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  

We look forward to welcoming your application. 

  • PV Associate

    1 day ago

    Pune, Maharashtra, India Ergomed Full time ₹ 1,04,000 - ₹ 1,30,878 per year

    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...

  • PV Associate

    1 hour ago

    Pune, Maharashtra, India PrimeVigilance Full time

    Job DescriptionCompany DescriptionWe 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,...

  • Pharmacovigilance Associate

    5 days ago

    Pune, India SYS Research Full time

    **Writing generic RMPs (data collection, Log of changes preparation, validation of finalised RMP)**: - **Coordinating simple generic RMPs** - **Drafting of responses to requests from regulatory agencies concerning RMP, as needed**: - **Ensuring that all tasks are performed in line with relevant predefined procedures**: - **Cooperation with other other...

  • Senior Drug Safety Associate

    3 days ago

    Pune, Maharashtra, India EVERSANA Full time

    Company DescriptionAt 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...

  • Senior Control Systems Engineer

    5 days ago

    Pune, Maharashtra, India beBeeEngineer Full time

    Job DescriptionThe primary function of this role is to coordinate the design, implementation, and maintenance of control systems engineering for SCADA systems. This includes writing specifications, design documents, evaluations, and performance assessments associated with control and equipment protection, construction, operation, and maintenance of the...

  • Process Executive

    21 hours ago

    Pune, Maharashtra, India Cognizant Full time

    **Team Lead - CDM/PV** **Qualification**: Graduate/Post Graduate/ Doctorate degree in life sciences/Pharmacy/Medical sciences/Registered Nurse ** Responsibility**: **Business/ Customer**: - Minimal Customer interaction under guidance. - Understands Domain Process/sub process, functions, terminologies (such as SOP, QC checklists). - For PV/Complaints...

  • Clinical Research Associate

    4 weeks ago

    Pune, Maharashtra, India Sun Pharmaceutical Industries Full time

    Job Location Pune YOUR TASKS AND RESPONSIBILITIES Perform site feasibility identify potential investigator negotiate study budget with potential investigators finalization of investigators sites and execution of CDA and study-related contracts Preparation and submission of study documents for EC permission for respective study across centers ...

  • Medical Information Associate

    1 week ago

    Pune, Maharashtra, India Ergomed Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    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 and...

  • Pv Associate

    5 days ago

    Pune, Maharashtra, India PrimeVigilance Full time

    **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,...

  • 3 Days Left: Medical Information Associate

    4 days 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...