Ergomed

Runs clinical trials and monitors drug safety

Senior PV Associate

Regulatory & Quality (Life Sciences)Posted on Nov 10

Full-timeRaleigh, NC, USANo salary listedRemote

About the Job

Requirements

Have a life science graduate, pharmacy, nursing, or other healthcare-related qualification, or experience in pharmacovigilance.
Have a minimum of 1 year of work experience in pharmacovigilance.
Have organization skills, including attention to detail and multitasking.
Have management skills, including time and issue management.
Have advanced spoken and written English.
Have advanced literacy in Microsoft Office.

Responsibilities

Provide support to other activities undertaken by the project team on behalf of the client and the company.
Perform activities in the scope of the ICSR management unit within the agreed extent and timeframe, including processing Individual Case Safety Reports (ICSs) from all sources in compliance with applicable regulations, PrimeVigilance procedures, client-specific requirements, and timelines.
Perform ICSR follow-up.
Manage serious adverse events and suspected unexpected serious adverse reactions, including unblinding, clinical trial reconciliation, protocol review, and Safety Management Plan review.
Perform clinical and partner reconciliation.
Handle personal data protection.
Handle product quality complaints and interact with Quality Assurance.
Interact with Medical Information.
Perform Medical Dictionary for Regulatory Activities and World Health Organization coding.
Prepare database outputs and reports, including data for monthly client reporting.
Manage workflow and resources.
Support pharmacovigilance processes related to ICSR management within PrimeVigilance and for clients.
Perform tasks assigned under standard operating procedures to more junior positions, as applicable to a more senior colleague.
Support the Regulatory Affairs and Pharmacovigilance Network Department as needed, including acting as the Local Contact Person for Pharmacovigilance for the specified country and as the Person Responsible for Local Screening for the designated language, as agreed with the line manager.

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
Collaborative Partnerships

We look forward to welcoming your application.

About the Company

Ergomed

Runs clinical trials and monitors drug safety

Ergomed manages clinical trials and drug safety for biotechnology and pharmaceutical companies, with a focus on complex cancer and rare-disease studies. Its clinical research business supports development from early testing through studies after approval, with services adapted to difficult patient populations. Teams plan trials, recruit patients, monitor study sites, and analyze results under paid service contracts. PrimeVigilance tracks medicine safety and answers medical inquiries, while ADAMAS Consulting advises clients on quality and regulatory compliance across drug development. Ergomed was founded in 1997 and has its global headquarters in Guildford, Surrey, United Kingdom.

Company size: 1,001-5,000
Company stage: Not listed
Total funding: Not listed
Headquarters: Guildford, United Kingdom
Founded: 1997

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