Pharmacovigilance & Safety

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Full service vigilance support

Our vigilance team is comprised of physicians, pharmacists and life science professionals who provide full vigilance support for products such as generics, innovators and advanced therapies. Since 2003, we have delivered comprehensive, end-to-end high-quality pharmacovigilance services to our clients and have expanded our services into other vigilance categories such as medical device vigilance, veterinary pharmacovigilance and cosmetovigilance.

From our strategically-located European global pharmacovigilance hubs, we offer cost-effective solutions for global pre- and post-approval pharmacovigilance, as well as related services in product safety (medical device vigilance, vetvigilance, cosmetovigilance). In addition, we have highly skilled experts in multiple countries to better serve your local needs with no subcontracting.

Our vigilance team

The Excelya advantage

We have implemented a specialized recruitment approach to attract the right talent for the right pharmacovigilance tasks globally and regionally.

Our strength is in our people, who possess strong academic backgrounds, deep knowledge of legislation, years of hands-on experience in pre- and post-approval projects for large and mid-size pharma, device manufacturers, etc.

Year after year, high retention rates secure continuity and are a basis for expansion. We add not only value to your system but build and sustain your image and reputation.

The role of Pharmacovigilance


Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of the adverse effects of using pharmaceuticals and other problems that can result from medicine use.

A combination of the Greek word pharmakon, (drug) and the Latin vigilare (to keep awake or alert/to keep watch), the objective of pharmacovigilance is to mitigate risk and monitor the use, dosage and effectiveness of drugs already on the market.

Data which sparks an investigation can surface from multiple sources, but mainly stems from new clinical trials, from unsolicited reports, or from data from post-authorization studies. This data is collected into a central Safety Database, which signals risks based on any concerning spikes or anomalies of data.

Should there be any cause for concern flagged regarding any drug or medical device, a pharmacovigilance risk assessment will be required.

The outcome of such activities include: changes in the recommended dosage for certain demographics, additional instructions for the consumer, more knowledge about side effects, or even the withdrawal of a drug from the market.

In summary, Pharmacovigilance is a practice put in place with patients’ best interest at heart, and aims to:

  • Detect and investigate problems related to product use
  • Communicate findings in a timely manner
  • Undertake benefit-harm assessments
  • Improve patient safety
  • Encouraging the safe and rational use of products
Global reach, local teams

Specific and extensive Pharmacovigilance experience from our PV & Safety hubs

excelya FSP

4 European Safety Hubs:

  • Athens (Greece)
  • Paris (France)
  • Sofia (Bulgaria)
  • Istanbul (Turkey)

…covering project management in EU and non-EU, including MENA region.


  • Own-developed and mature SOPs
  • In-house safety database
  • Experienced project management

Our PV capabilities







A full spectrum of vigilance services

Excelya’s Pharmacovigilance and Safety department has a dedicated, experienced and qualified team in order to provide services for assessing the performance and quality of pharmacovigilance activities. Our services include:


Post Marketing Pharmacovigilance Support

  • Set-up and implementation of Pharmacovigilance System, including writing/review of SOPs and preparation/maintenance of Pharmacovigilance System Master File (PSMF)
  • Provision of Qualified Person for Pharmacovigilance (QPPV) in Europe, Turkey, Middle East and African Region
  • 24/7 Pharmacovigilance cover
  • Provision of Local contact person for Pharmacovigilance/ Local QPPV in multiple countries
  • International Literature Review and Local Literature Review
  • ICSR handling: triage, assessment, MedDRA coding, processing
  • Inhouse Safety Database
  • Electronic expedited reporting (e.g. through EudraVigilance)
  • Registration and maintenance of product information in XEVMPD
  • Safety signal detection and Management
  • Aggregate reports (PSUR/ PBRER/ PADERs)
  • Operation of Risk Management System (RMS), including the writing of Risk Management Plan (RMP) and the preparation of materials for Risk Minimisation Activities
  • Direct Healthcare Professional Communication (DHPC) management
  • Controlled Distribution Activities as per Risk Management Plan
  • Safety Data Exchange Agreements (SDEA) preparation/review and maintenance
  • Training
  • Regulatory Intelligence Services
  • Authority Website Monitoring
Excelya biotech consulting

Clinical Trial Safety

  • Safety review/preparation of safety content for clinical trial documents (including Protocol, SAP, CSR)
  • Preparation of Safety Monitoring/Management Plans for clinical trial conduct
  • Individual case safety report (ICSR) processing for Serious Adverse Events (SAEs)
  • Inhouse Safety Database
  • Expedited reporting (e.g. through EudraVigilance)
  • Aggregate report preparation and reporting (e.g. DSUR)
  • Training

Veterinary Pharmacovigilance

  • Set up and implementation of Pharmacovigilance System, including writing/review of SOPs
  • Creation and Maintenance of the Detailed Description of the Pharmacovigilance System (DDPS)
  • Provision of Qualified Person Responsible for Pharmacovigilance (24/7 cover)
  • Adverse event processing and reporting and efficient handling of communication of safety alerts (off-label, lack of efficacy, potential environmental problems)
  • Preparation/Writing/Submission of PSURs
  • Safety signal detection and management
  • Screening of literature (both Global and Local) for identification of adverse events
  • Safety Data Exchange Agreements (SDEAs) set up and maintenance
  • EudraVigilance set-up, maintenance & registration
  • EudraVigilance Veterinary Medicinal Product Dictionary (EVVetMPD) maintenance
  • Training

Medical Device Vigilance

  • SOP creation and maintenance
  • Collection and follow-up of events
  • Investigation and assessment of Incidents and near-Incidents
  • Screening of literature for identification of events with medical devices
  • Reporting Incidents with Manufacturer’s Incident Report
  • Preparation and submission of Periodic Summary/Trend Reports
  • Implementation and reporting of Field Safety Corrective Action
  • Preparation, translation, distribution to receivers and submission to Health Authorities of Field Safety Notices
  • Training

Pharmacovigilance Auditing

  • Pre- audit and Pre-inspection preparation and support
  • PV system Auditing
  • Gap analysis on SOP and PV system


  • Client staff training on pharmacovigilance or other product safety vigilance focused on the specific needs and tailor-made to the client
  • Training on audits and inspections
  • Excelya training programs on specific vigilance topics


  • SOP creation and maintenance
  • Assist Responsible Person within EU for safety related tasks
  • Preparing Safety Assessment Reports for placing cosmetic products on the market
  • Provide market surveillance system for Serious Undesirable Effects (SUEs)
  • Handling Undesirable Effects / Serious Undesirable Effects (SUEs – SUE Form A)
  • Causality Assessment
  • Evaluation of trend or signal detection
  • Safety Data Exchange Agreements (SDEAs) set up and maintenance
  • Training
Excelya full service

Why Excelya?


95 highly trained pharmacovigilance professionals ready to go


Over 150 pharmacovigilance projects completed in the past 4 years


Highly qualified team (Master, PhD), more than 19 years experience


Excelya seamlessly pairs specific, local knowledge with international reach

Add value in a way that best serves your organizations' needs

Quality has been the main focus of our pharmacovigilance and product safety services since 2003. We are proud of our client centric company culture highly sensitive to individual needs.

Excelya offer cost-effective solutions for global pre- and post-approval pharmacovigilance as well as related services in product safety (device vigilance, vetvigilance, cosmetovigilance, etc.). In addition, we have deep roots on a local level in multiple countries, enabling us to serve your local needs without subcontracting.

During the many years of our product safety operations, we have grown vigilance teams with targeted expertise to achieve operational stability. The Excelya difference comes with our lean management style, agile project implementation and short timelines, and our efficient pathways of communication.

Pharmacovigilance Proficiency

We have new best-in-class resource management standards adapted to global capabilities and new ways of considering cycle management.

Our results speak for themselves: Excelya PV studies received exceptional internal and external results, with 100% of them flagging no critical or major findings.

With the winning combination of best-in-class knowledge and demonstrable internal processes, your PV exploits are in good hands with us.