PV Associate/Literature

Posted 4 Days Ago
Be an Early Applicant
2 Locations
Entry level
Biotech • Pharmaceutical
The Role
The PV Associate will support literature monitoring and screening activities in compliance with regulations. Duties include developing literature search strategies, conducting searches, maintaining records, and assisting in peer reviews. The role involves collaboration with clients and team members to ensure high-quality service and readiness for regulatory inspections.
Summary Generated by Built In

Company Description

PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative safety services for pharmaceutical, generic and biotechnology companies. Our founders and leaders have an unrivalled reputation in the sector with a network of expert associates across the world.

Job Description

  • Assures and exerts activities leading to effective cooperation with clients in the area of literature monitoring
  • Contributes to achieving company´s goals and objectives
  • Ensures that the Literature Screening responsibilities and activities are managed in a cost-efficient manner of the highest quality and in compliance with global regulations and company policies and in accordance with any Pharmacovigilance (PV) agreement.
  • Works under supervision of more experienced colleague
  • To assist with the development of literature search strategy
  • To participate in weekly and ad hoc literature searches
  • To participate in weekly and ad hoc literature screening activities to identify potential ICSRs and other relevant safety related information pertaining to nominated products
  • To assist with ordering copies of full literature articles for review
  • To maintain a record and track all literature abstracts screened and full literature article reviewed, with actions taken and the reason
  • To forward any ICSRs to PV Associates for data entry into the global drug safety database
  • File other relevant safety related information for use in signal detection and PSURs
  • To participate in the screening of local non-indexed literature as required
  • To assist in peer review QC of abstracts
  • Accessing EV on daily basis and downloading MLM search and MLM ICSR results (excel spreadsheets)
  • Tracking all the MLM search results, MLM ICSRs list downloads and exported ICSRs
  • Uploading the MLM search results and the list of ICSRs in the designated PrimeVigilance Portal area
  • Reviewing the list of ICSRs daily
  • Checking all urgent/immediate issues have been addressed in a timely manner;
  • Keeping the EMA MLM Literature Screening Tracker up to date with the latest information received from the EMA
  • Reporting to the unit head and more senior unit team members, and providing them with regular updates regarding project status and metrics concerning enquiries
  • To assist with the development and improvement of literature screening processes and procedures
  • Assisting in departmental regulatory inspection preparedness for the company PV system in the EU and actively participating in PV inspections or audits

Qualifications

  • Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science), previous experience is not required. 

  • People who are excited to learn and contribute to patient safety 

  • Time and issue management, delegation, organization and multitasking skills with good attention to detail 

  • Strong interpersonal and communication skills 

  • Advanced English skills, both verbal and written, at least B2 

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

We look forward to welcoming your application. 

The Company
HQ: Raleigh, NC
535 Employees
On-site Workplace
Year Founded: 1997

What We Do

Founded in 1997, Ergomed is a global provider of high-quality services to the biopharmaceutical industry, spanning all phases of clinical trials, post-approval pharmacovigilance, and medical information. Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance (PV) solutions, integrated under the PrimeVigilance brand, and Ergomed Clinical Research, a complete, global Phase I-IV clinical development and trial management services with a strong heritage in the development of drugs in rare diseases and oncology.

• 1,400+ highly qualified professionals
• Global full-service CRO
• 25+ years of experience
• Therapeutic specialization in oncology
• Strong expertise in rare disease trials
• Robust clinical safety system
• Choice of leading drug safety databases

Our key services include:
• Clinical Research Services
• Pharmacovigilance
• Medical Information
• Regulatory
• Medical Writing
• Site Management
• Study Physician Support
• Biostatistics
• Patient Study Support

Similar Jobs

Banja Luka, Republika Srpska, BIH
645 Employees
Banja Luka, Republika Srpska, BIH
1939 Employees
Hybrid
Sarajevo, Federacija Bosne i Hercegovine, BIH
495 Employees

Ergomed Logo Ergomed

PV Associate

Biotech • Pharmaceutical
2 Locations
535 Employees

Similar Companies Hiring

Novo Nordisk Thumbnail
Software • Pharmaceutical • Healthtech
Bagsværd, DK
69000 Employees
Zealthy Thumbnail
Telehealth • Social Impact • Pharmaceutical • Healthtech
New York City, NY
13 Employees
Cencora Thumbnail
Pharmaceutical • Logistics • Healthtech
Conshohocken, PA
46000 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account