Senior PV Associate

PrimeVigilance Ltd.; Raleigh (NC); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Training and career development

Friendly, supportive environment

Global collaboration with English as a

English as company language

Job summary

PrimeVigilance Ltd. is seeking a Pharmacovigilance professional to support ICSR management, ensuring accurate processing and timely follow-up of safety reports. You will collaborate with the project team and clients, maintaining data integrity and regulatory compliance.

Responsibilities include SAE/SUSAR handling, coding with MedDRA/WHO, and producing monthly reports. The role requires at least 1 year in PV, strong English, and MS Office proficiency, with opportunities for training and growth in

Qualifications

• Life science graduate, pharmacy, nursing or other healthcare qualification.
• Minimum 1 year of work experience in pharmacovigilance.
• Strong organizational skills with attention to detail and multitasking.
• Excellent English (spoken and written).
• Advanced literacy in MS Office applications.

Responsibilities

• Provide support to PV activities within the ICSR management unit.
• Process ICSRs from all sources in compliance with regulations and client requirements.
• Perform ICSR follow up and SAE/SUSAR management tasks.
• Handle reconciliation with clinical partners and data protection.
• Interact with Medical Information and Quality Assurance teams; apply MedDRA and WHO coding.
• Produce database outputs and monthly client reports; assist workflow and resource management.

Skills

Pharmacovigilance

Attention to detail

Multitasking

Time management

Advanced English

Education

Healthcare-related qualification

Tools

MS Office

Job 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 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.

Job Description

• Providing support to other activities undertaken by the project team on behalf of the client and the company
• Performing activities in the scope of ICSR management unit within agreed extent and timeframe (including, but not limited to):
  • Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines
  • Performing ICSR follow up
  • SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review)
  • Reconciliation (clinical, partners)
  • Personal data protection
  • Product Quality Complaint handling and interaction with Quality Assurance
  • Medical Information interaction
  • MedDRA and WHO coding
  • Database Outputs and Reports (including data for monthly reporting to clients)
  • Workflow & resource management
• Support of PV processes related to the ICSR management within PrimeVigilance and also to clients
• More senior colleague may perform tasks assigned as per SOP to more junior position
• Performing activities in the scope of ICSR management unit within agreed extent and timeframe
• Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

Qualifications

• Life science graduate, pharmacy, nursing, other healthcare related qualification or experience in pharmacovigilance
• Minimum 1 year of work experience in pharmacovigilance
• Organization skills, including attention to detail and multitasking
• Management skills, including time and issue management
• 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

We look forward to welcoming your application.