Local Contact Person for PV Globally
The Tepsivo network of Local Contact Persons for PV (LCPPVs), Local Qualified Persons for PV (QPPVs) or Local Safety Officers (LSOs) spans all global regions and covers more than 150 countries. If you need local Pharmacovigilance expertise, we are here to support you, anywhere in the world.
If you need local Pharmacovigilance expertise, we are here to support you, anywhere in the world.
What is typically in scope of this role?
- Legally needed role and responsibility of Local Qualified Person for Pharmacovigilance or Local Contact Person for PV
- Role of Local Safety Officer/Patient Safety Lead
- Liaising with National Competent Authorities
- Local language support and translation
- Literature monitoring in local language journals (not indexed in global databases)
- Implementation of risk minimization measures locally
- Regulatory Intelligence
- Support with preparation of local aggregate reports and PSMFs
- Local ADR/ICSR intake and follow-ups
- Scientific Advice
- Availability as needed (24/7, business hours)
- Other ad hoc activities
Why Tepsivo?
Are you placing your product in several countries or via centralized procedure in EU and realizing you may have to hire many new people to cover the role of national contact person for pharmacovigilance?
Does that sound like a lot of time effort and a massive cost to manage? Typically, it really has been.
Well… before Tepsivo joined the field.
Managing projects across all time-zones, involving 30+ countries with 60+ people is our bread and butter. Local PV operations is what we started to modernize and automate at first.
Running global operations of local contact persons has traditionally been a massive part of overall PV budgets with inexplicable inefficiencies all around.
We decided to change that.
Where do you need a local contact person for pharmacovigilance?
You may be facing this requirement in several places of the world wherever you may commercialize your product – and we can help anywhere. But where you are the likeliest to deal with this legal obligation is Europe.
The EU law provides that individual national competent authorities can request a national contact person for pharmacovigilance to be nominated next to the European-level EU QPPV. And indeed, roughly half the EU countries have that requirement!
Free Guide: National requirements for the LCPPV’s
We believe the common practice of charging fees for basic intelligence has no place in modern PV world. To help you out with your duties, we put together a comprehensive document listing specific LCPPV requirements for each EEA country. Feel free to use it as a handy guide to understand your obligations, whether you choose our services or not!
✓ Thorough sum-up
✓ Practical tips
✓ Exact legislation references
✓ Extends info from EMA
✓ Up-to-date (2022)
If you’re wondering what your obligations are at a national level, just give us a shout, tell us which countries you’re marketing your medicines in, and we’ll come back to you right away with an answer where the local contact person/QPPV is required.
Do you know your national PV obligations around the world?
National Pharmacovigilance requirements are very specific country by country and sometimes may not even be crystal clear. Depending on your market coverage, you might have the obligation to implement and maintain a local PV system in place, including the role of local QPPV and others.
To ensure that you’re in full regulatory compliance in all countries where your product is authorized for marketing, you may require local experts to navigate you. We’re happy to help.
And do you stay compliant with the rules?
Local PV requirements are not only difficult to navigate, they also change from time to time. Thorough global regulatory intelligence is key.
We closely monitor all national agencies and keep up to date with any changes. We make sure our clients always stay abreast of these and can respond in time to any new legislative developments.
Where exactly can we support you?
Europe
Austria
Belgium
Bosnia and Herzegovina
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Kosovo
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Moldova
Montenegro
Netherlands
North Macedonia
Norway
Poland
Portugal
Romania
Serbia
Slovakia
Slovenia
Spain
Sweden
Switzerland
Ukraine
United Kingdom
Americas
Aruba
Barbados
Belize
Bolivia
Brazil
Canada
Chile
Colombia
Costa Rica
Curacao
Dominican Republic
Ecuador
El Salvador
Guatemala
Guyana
Honduras
Jamaica
Mexico
Nicaragua
Panama
Paraguay
Peru
Suriname
Trinidad and Tobago
United States
Uruguay
Venezuela
APAC
Brunei
Cambodia
China
Hong Kong
India
Indonesia
Japan
Laos
Malaysia
Mongolia
Myanmar
New Zealand
Papua New Guinea
Philippines
Singapore
South Korea
Sri Lanka
Taiwan
Thailand
Vietnam
CIS
Azerbaijan
Georgia
Kazakhstan
Kyrgyzstan
Russia
Tajikistan
Turkmenistan
Uzbekistan
Mena
Bahrain
Egypt
Iraq
Israel
Jordan
Kuwait
Lebanon
Morocco
Oman
Pakistan
Qatar
Saudi Arabia
Syria
Tunisia
Turkey
United Arab Emirates
Yemen
Sub-Saharan Africa
Benin
Botswana
Burkina Faso
Burundi
Cameroon
Central African Republic
Chad
Democratic Republic of Congo
Djibouti
Ethiopia
Gabon
Gambia
Ghana
Guinea
Ivory Coast
Kenya
Lesotho
Madagascar
Malawi
Mali
Morocco
Mozambique
Namibia
Niger
Nigeria
Republic of the Congo
Rwanda
Senegal
Sierra Leone
South Africa
Tanzania
Togo
Uganda
At Tepsivo, we value modernization, quality, and cost efficiency. With our local PV network, you can be guaranteed that you fully utilize:
✓ Today’s technology through our automated service delivery application
✓ Highly experienced local PV experts thoroughly qualified and regularly audited
✓ Appropriate pricing due to effective management with zero administrative costs
Whether your project covers 2 or 80 countries, it makes no difference to us. With our automated processes and technology, we can set your project up within 2 weeks and manage everything across all regions and time-zones effectively, quickly, and to the highest standards of quality.
And of course, at the lowest possible cost to you…
Just contact us and we’ll show you.
Let’s have a chat
Whatever you needs are, we look forward to getting in touch with you.
Feel free to drop us a message and we will contact you right away.
Tepsivo Oy | Urho Kekkosen katu, 4-6 E, 00 100, Helsinki, Finland | VAT number FI31367614 | [email protected] | +358 402 204 698 | Privacy policy
