Andela Caleta Car
Senior PV Manager, Literature
Zagreb
Summary
Dynamic Senior PV Manager with extensive experience at PrimeVigilance, excelling in operations management and team leadership. Proven track record in enhancing compliance and quality standards while driving process improvements. Adept at training staff and developing strategic plans, ensuring audit readiness and robust documentation for successful pharmacovigilance outcomes.
Overview
10
10
years of professional experience
2
2
Languages
Work History
Senior PV Manager/Literature
PrimeVigilance
04.2023 - Current
- Ensures that all contracted Literature Screening responsibilities and activities are managed in compliance with regulations and company policies and in accordance with any PV agreement
- Manages the Literature Unit
- Reviews and implements efficiency strategies whilst maintaining the highest quality of work
- Oversees the process of screening of literature and ensures compliance to relevant legislation
- Oversees the development and improvement of pharmacovigilance literature processes and procedures
- Oversees the management across all client projects to ensure that quality and compliance are always maintained
- Closely monitors compliance metrics and prepares compliance reports as required
- Provides training on specific literature topics as required
Mentors and trains new or more junior employees within the department - Supports the business and/or commercial team in pharmacovigilance aspects of the development of contracts and proposals with regards to literature
- Supports the Company by attending BID defense meetings and conferences as the pharmacovigilance expert
- Provides support in maintaining an excellent Quality Management System
- Ensures adequate resourcing for activities across all client projects
- Ensures the literature unit is always audit/inspection ready
Participates in Audits and Inspections - Provides literature support to ensure compliance on business practice
- Overviews workflow management
Writes PV Operational Guidelines and SOPs in the field of expertise - Develops PV training presentations
- Develops and maintains advanced knowledge of global regulations, guidelines, SOPs and writing practices
- Develops and maintains advanced knowledge of global biomedical databases
PV Manager/Literature
PrimeVigilance
10.2021 - 03.2023
- Managed and motivated employees to be productive and engaged in work.
- Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
- Controlled costs to keep business operating within budget and increase profits.
- Improved marketing to attract new customers and promote business.Leads and manages the Literature Screening Unit, ensuring full compliance with global PV regulations, company SOPs, and contractual obligations.
- Oversees literature screening activities across client projects, ensuring high quality, consistency, and inspection readiness.
- Drives process improvements and efficiency while maintaining compliance and quality standards.
- Prepares compliance reports, monitors KPIs, and ensures robust documentation for audits and inspections.
- Trains and mentors junior team members; delivers internal training on literature-related topics.
- Supports proposal development and represents the company as a PV expert in client meetings and conferences.
- Contributes to the development of SOPs, operational guidelines, and training materials.
- Maintains up-to-date expertise in global PV regulations and biomedical databases.
PV Officer/Literature
PrimeVigilance
07.2020 - 09.2021
- Manage or assist in the management of client projects involving Literature Screening
- To participate in weekly and ad hoc literature screening activities to identify potential Individual Case Summary Reports (ICSR) and other relevant safety related information pertaining to nominated products
- 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 Periodic Safety Update Reports
- To participate in peer review Quality Check of abstracts
Preparing monthly metrics - Assist in the training and mentoring of operational individuals
- Assist in the line management of operational individuals and participate in their ongoing evaluation and periodic appraisals
- Provide regular project updates regarding workload, project status and metrics
- Writing of procedures for literature screening processes and procedures
- Assisting in departmental regulatory inspection preparedness for the company pharmacovigilance system in the EU and actively participating in inspections or audits
PV Associate/Literature
PrimeVigilance
09.2016 - 06.2020
- 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
- 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
Radiology Technologist Intern
Clinical Hospital Centre Sisters of Mercy in Zagreb
08.2015 - 08.2016
- Produced high-quality images for accurate, reliable review and interpretation.
- Captured images using mobile equipment in operating rooms, emergency rooms, and patients' bedsides.
- Reviewed physicians' orders to determine medical imaging needs and operated radiologic equipment to capture, develop, and produce diagnostic images.
- Collaborated with radiologists to ensure optimal image quality, leading to precise diagnoses and effective treatment plans.
Education
Bachelor of Science - Medical Radiologic Technology/Science - Radiation
University of Applied Health Sciences Zagreb
Zagreb, Croatia 04.2001 -
Skills
Team leadership
Operations management
Strategic planning
Decision-making
Time management
Project management
Staff training and development
Multitasking Abilities
Adaptability and flexibility
Team collaboration
Work Planning and Prioritization
Timeline
Senior PV Manager/Literature
PrimeVigilance
04.2023 - Current
PV Manager/Literature
PrimeVigilance
10.2021 - 03.2023
PV Officer/Literature
PrimeVigilance
07.2020 - 09.2021
PV Associate/Literature
PrimeVigilance
09.2016 - 06.2020
Radiology Technologist Intern
Clinical Hospital Centre Sisters of Mercy in Zagreb
08.2015 - 08.2016
Bachelor of Science - Medical Radiologic Technology/Science - Radiation
University of Applied Health Sciences Zagreb
04.2001 -
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