About PharSafer

Founded in 2003 by Dr Graeme Ladds, PharSafer® is a specialist Contract Research Organisation (CRO) in Global Clinical and Post Marketing Drug Safety, and Medical Services, with a wealth of experience in Pharmacovigilance, Auditing and Medical Affairs – and the various, numerous and extensive legal safety/medical obligations for licence holders to comply with – as well as Regulatory Strategy for the best methods for obtaining scientific advice concerning licence submissions and approvals.

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Together with our sister company which focuses on Training: SaPhar, PharSafer® continuously seeks new and innovative ways to provide added value for our global clients – going above and beyond expectations and optimising processes and procedures involved with clinical and post marketing drug safety and licencing approach.

Our ability to offer first-class services in Pharmacovigilance, Regulatory Affairs, Training, Auditing, Medical Affairs and IT Informatics means that, for many clients, we operate as their Pharmacovigilance and Medical Departments – guiding them through the labyrinth of drug safety and medical legislation, all in the interests of ensuring patient safety and client compliance. We love what we do.

We love finding solutions. Quite simply, we are by far...

Your leading partner in Drug Safety.

PharSafer® can act as your complete Pharmacovigilance & Medical Services department, performing all of the activities expected of your own team. This includes compliance with the necessary and varied global legislation and the ability to provide accurate information to Healthcare professionals and patients, ensuring that your business achieves consistently high regulatory performance.

To deliver this first-class service, we offer a wide range of services and solutions that can be identified by the following departmental areas:

Our Mission

At PharSafer®, our mission is simple but powerful: To keep each and every one of our clients compliant – as the global environment evolves – and lead them through the maze that is drug safety, with exceptional quality of service forever at the forefront of our thoughts.

“To be recognised as one of the top quality and knowledgeable CRO’s in the world for Pharmacovigilance & Medical Services within the next 5 years”.

Dr Graeme Ladds, CEO

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“We are passionate about protecting patients and keeping every one of our clients compliant”

Our purpose is clear. Like a family, we care deeply about our customers; our service; our reputation; our customer’s reputation, and our people.

For this reason, people really seem to enjoy working with us. We relish the challenge of simplifying the complex and confusing, and solving issues for our partners, which is both thanks and testament to our amazing people, our first-class services and our global reach.

We love what we do. We love finding solutions.

Quite simply, we are by far… Your leading partner in drug safety.

Our Mission

At PharSafer®, our mission is simple but powerful: To keep each and every one of our clients compliant – as the global environment evolves – and lead them through the maze that is drug safety, with exceptional quality of service forever at the forefront of our thoughts.

“To be recognised as one of the top quality and knowledgeable CRO’s in the world for Pharmacovigilance & Medical Services within the next 5 years”.

Dr Graeme Ladds, CEO

Read More

“We are passionate about protecting patients and keeping every one of our clients compliant”

Our purpose is clear. Like a family, we care deeply about our customers; our service; our reputation; our customer’s reputation, and our people.

For this reason, people really seem to enjoy working with us. We relish the challenge of simplifying the complex and confusing, and solving issues for our partners, which is both thanks and testament to our amazing people, our first-class services and our global reach.

We love what we do. We love finding solutions.

Quite simply, we are by far… Your leading partner in drug safety.

Our Values

Our values and those shared by our people are what set us apart from other providers and help to make us the company we are today.

Above all else, we prioritise patient safety and consider this to be our fundamental value, in which all of our processes and procedures are based upon.

It is from this fundamental value and our shared commitment that we are able to easily outline our primary objectives, enabling us to grow and build upon the successes achieved over the years, and reach new milestones for the company together.

  • We Value Patient Safety
  • We Work With People Over Staff
  • We Deliver A First-Class Service
  • We Are Transparently Unique
  • We Are Compliant
Our Journey
Our Journey
Our Locations

PharSafer House is located in Ripley, United Kingdom and is the Global Operations Centre for the group, acting as the central communications hub where all activities are quality assessed before sending to clients or Regulatory Agencies.

With approximately 70% of our clients residing from outside the UK and reporting procedures in place and ready to meet safety reporting regulation in over 130 countries (clinical and post-marketing), PharSafer® is truly a global organisation.

Locations Placeholder
Locations
Note: Our expert team possess experience in the safety reporting rules for many more countries than those listed above, for drugs; devices; biologics; biosimilars; cosmetics; advanced therapies and vaccines, in a variety of different settings including clinical; post-marketing; investigator-initiated studies; compassionate use; post-marketing studies; patient registries and post-marketing studies.
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We proudly serve as a specialist provider to an extensive clientele portfolio that comprises of both global industry leaders and national enterprises across diverse markets.

Our client spectrum encompasses multinational corporations with expansive product portfolios across various countries, as well as national companies focusing on fewer products within specific regions, and cater to the following array of product types, strategically addressing the pharmaceutical landscape in the USA, Canada, Europe, Southeast Asia, Australia, and Africa:

  • Biologics
  • Vaccines
  • Devices
  • Generics
  • Cosmetics
  • OTC
  • Advanced Therapy
  • Innovative

The products owned by our clients are equally diverse and range from your everyday pharmaceutical products, to rare disease (Orphan and Ultra-Orphan); generic; Drug/Device; OTC; generic; innovator and advanced therapy, including gene therapy and stem cell therapies, and many more.

No matter the size or location, we offer tailored solutions to meet the unique needs and aspirations of each client, ensuring excellence in every aspect of our service delivery.

Visit our services

Main Locations:

PharSafer House is located in Ripley, United Kingdom and is the Global Operations Centre for the group, acting as the central communications hub where all activities are quality assessed before sending to clients or Regulatory Agencies.

  • UK, India, Spain and USA
Ripley, UK:

PharSafer House is located in Ripley, United Kingdom and is the Global Operations Centre for the group, acting as the central communications hub where all activities are quality assessed before sending to clients or Regulatory Agencies.

  • HQ located in Ripley, UK
  • Quality center for our global brand
  • Outputs to Regulatory Agencies and clientele
  • Technical and administration staff
  • Facilitating both day and night, operating 24/5
Read More about Ripley, UK
PharSafer® UK is responsible for performing the following PV tasks:
  • Data Entry
  • Quality Review
  • Literature Review
  • ICSR Submissions
  • ICSR Triage
  • Medical Support
  • PSURs/PBRERs
  • DSURs
  • Medical information
  • Safety Reviews
  • Signal Detection
  • QA
  • RMPs/REMs
  • SOP Writing
  • Auditing
  • Due Diligence
  • Training

PharSafer® UK manages the following:
  • Medical Information
  • Quality Assurance (including training management)
  • IT and Database Support
  • Client Liaison
  • Administration
  • Finance
  • Marketing
Colleagues around the globe:
  • Global offices strategically placed in India and Spain
  • Local expertise and highly-skilled international workforce
  • Provide a complete 24/7-365-day service operation
  • Perform the volume of work necessary for safety assessments, case processing, literature searching and literature assessments, and achieving our business development goals
New Delhi, India:
  • Offices located in New Delhi, India
  • PharSafer® UK trained Pharmacovigilance Director
  • Collaborate across offices as a team to provide support to PharSafer® clients
  • All staff are trained using the same SOPs and training materials as the UK office
Read More about New Delhi, India
PharSafer® India operates in collaboration with PharSafer® UK to perform the following:
  • Data Entry
  • Quality Review
  • ICSR Triage
  • Literature Review
  • QA
  • ICSR Submissions
  • Training
  • Medical Support
  • PSURs/PBRERs
  • SOP Writing
Mallorca, Spain:
  • Location where EU QPPV and EU PSMFs are registered
  • Also used for business development purposes
  • Besides QPPV services, other pharmacovigilance activities are delegated to UK and India offices
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