Philipp Hofmann - Director Pharmacovigilance...

Q: Where is Philipp based?

Philipp is based in Frankfurt am Main, Germany .

Q: What languages does Philipp speak?

Philipp speaks the following languages: German (Native), English (Advanced), French (Advanced) .

Q: How many years of experience does Philipp have?

Philipp has at least 20 years of experience. During this time, Philipp has worked in at least 7 different roles and for 4 different companies . The average length of individual experience is 3 years and 10 months . Note that Philipp may not have shared all experience and actually has more experience.

Q: What is Philipp's latest experience?

Philipp's most recent position is Director Pharmacovigilance, Global QPPV at Navitas Life Sciences .

Q: What companies has Philipp worked for in recent years?

In recent years, Philipp has worked for Navitas Life Sciences .

Q: Which industries is Philipp most experienced in?

Philipp is most experienced in industries like Pharmaceutical and Healthcare .

Q: Which business areas is Philipp most experienced in?

Philipp is most experienced in business areas like Quality Assurance , Research and Development , and Project Management . Philipp also has some experience in Marketing .

Q: Which industries has Philipp worked in recently?

Philipp has recently worked in industries like Pharmaceutical .

Q: Which business areas has Philipp worked in recently?

Philipp has recently worked in business areas like Project Management , Quality Assurance , and Research and Development .

Recommended expert

Frankfurt am Main, Germany

Experience

Apr 2022 - Dec 2025

3 years 9 months

Frankfurt, Germany

Director Pharmacovigilance, Global QPPV

Navitas Life Sciences

Management of the global Pharmacovigilance (PV) department
Manage post-authorization PV and safety in clinical trials (all phases)
EU-QPPV, National Safety Officer (Stepwise Action Plan Officer), Medical Information Officer
Management and reporting of Adverse Drug Reactions and Serious Adverse Events
Maintain and develop PV system
Medical project management (particularly multinational clinical trials)
Medical review of documents and data for projects
Support of preparing clinical research documents, e.g. study protocol, DSURs, PSURs, safety management plan, final report
Internal and external medical trainings
Active participation in business development for PV

Jan 2017 - Mar 2022

5 years 3 months

Frankfurt, Germany

Head of Pharmacovigilance, EU QPPV

Navitas Life Sciences

Management of the global Pharmacovigilance (PV) department
Manage post-authorization PV and safety in clinical trials (all phases)
EU-QPPV, National Safety Officer (Stepwise Action Plan Officer), Medical Information Officer
Management and reporting of Adverse Drug Reactions and Serious Adverse Events
Maintain and develop PV system
Medical project management (particularly multinational clinical trials)
Medical review of documents and data for projects
Support of preparing clinical research documents, e.g. study protocol, DSURs, PSURs, safety management plan, final report
Internal and external medical trainings
Active participation in business development for PV

Jan 2014 - Dec 2017

4 years

Paris, France

Head of Pharmacovigilance, EU-QPPV

Orphan Europe

Collection, validation and submission on time of all PV data
Reporting within deadlines to Health Authorities and Ethics Committees
Quality management including development and maintenance of SOPs
Detection and management of PV signals
Monitoring of the literature
Monitoring and communication on the safety profile of the company’s products
Perform global human risk assessment, evaluation of the risk-benefit ratio
Supervision of the handling of adverse drug reactions and adverse events
Provide safety information to health care professionals or internally
Establish and maintain the PV system to ensure the collection and the validation of safety data
Participate in the maintenance of the PV quality management system
Liaise with licensors and licensees to exchange drug safety information
Participate in the drafting of Safety Data Exchange Agreements with distributors
Conduct international and external audits and prepare inspections
Global support for clinical programs and medical review in global projects/studies
Collaboration on safety-related study documents
Supervise the drafting of safety related documents, e.g. periodic reports
Perform and control training in international GVP guidelines according to legal regulations
Monitoring of post-marketing commitments
Support during regulatory submissions
National Safety Officer (Stepwise Action Plan Officer) for Germany

Jan 2012 - Dec 2013

2 years

Bad Homburg, Germany

Director Global Safety

Fresenius Kabi Deutschland

Global human risk assessment, evaluation of the risk-benefit ratio for generic products: volume therapy, parenteral nutrition, oncology and standard solutions
Identification and assessment of adverse events from clinical studies and adverse drug reactions in post-marketing PV
PSUR writing
Quality management including writing SOPs, auditing in a GMP/GCP environment and designing a new role concept for the global PV personnel
Heading the Corporate Labeling Committee for non-urgent label changes and approving company-sponsored studies and IITs as part of the Global Trial Committee
Global support for clinical programs and medical review in global projects/studies
Collaboration on safety-related study documents
Role of the Information Officer for approval of international scientific marketing material
Training in international GCP guidelines according to legal regulations
Personnel management
Medical review of study documents (CRFs)
Provide training and participation in investigator meetings
Preparation of a white paper on biosimilars
Maintaining an emergency number for medical emergencies in clinical trials
Business development of the pharmaceutical business
Approval of international scientific marketing material in a Medical Affairs function

Jan 2009 - Dec 2011

3 years

Bad Homburg, Germany

Safety Officer Germany, Deputy EU QPPV

Fresenius Kabi Deutschland

Jan 2008 - Dec 2011

4 years

Bad Homburg, Germany

Medical Manager Vigilance, Deputy EU QPPV

Fresenius Kabi Deutschland

Global human risk assessment, evaluation of the risk-benefit ratio for generic products: volume therapy, parenteral nutrition, oncology and standard solutions
Identification and assessment of adverse events from clinical studies and adverse drug reactions in post-marketing PV
PSUR writing
Quality management including writing SOPs, auditing in a GMP/GCP environment and designing a new role concept for the global PV personnel
Heading the Corporate Labeling Committee for non-urgent label changes and approving company-sponsored studies and IITs as part of the Global Trial Committee
Global support for clinical programs and medical review in global projects/studies
Collaboration on safety-related study documents
Role of the Information Officer for approval of international scientific marketing material
Training in international GCP guidelines according to legal regulations
Personnel management
Medical review of study documents (CRFs)
Provide training and participation in investigator meetings
Preparation of a white paper on biosimilars
Maintaining an emergency number for medical emergencies in clinical trials
Business development of the pharmaceutical business
Approval of international scientific marketing material in a Medical Affairs function

Jan 2006 - Dec 2008

3 years

Hanover, Germany

Annual Safety Report Manager (Medical Writer)

Solvay Pharmaceuticals

Set-up and maintenance of global structures for periodic safety reporting in clinical safety including Annual Safety Reports, Risk Management Plans and IND-Annual Reports.

Industry Experience

See where this freelancer has spent most of their professional time.

Experienced in Pharmaceutical and Healthcare.

Pharmaceutical

Healthcare

Business Area Experience

See which departments and functions this freelancer has contributed to most.

Experienced in Quality Assurance, Research and Development, Project Management, and Marketing.

Quality Assurance

Research and Development

Project Management

Marketing

Summary

building up and leading a department of 50 members of staff, setting up a new database, being responsible for the global and local PV system, being a global QPPV, heading the QPPV office and the department of PV worldwide, leading inspections by health authorises

Skills

Pv Database Including Meddra
Understanding Of Regulatory Guidelines (Fda, Ema, Who)
Concise Communication Skills Internally And Externally
Attentive To Details For Documents And Adrs
Adaptive To New Developments In Pv
Regulatory And Scientific/medical Knowledge
Highly Collaborative With Other Departments And Units Within Pv
Critical Thinking
Pragmatic Problem Solving
Pv Strategy And Operations
Audit & Inspection Leadership And Readiness
Team Building And Resource Management
Strategic Decision-making
Project Management
Vendor Management

Languages

German

Native

English

Advanced

French

Advanced

Education

Oct 2011 - Jun 2013

University Of Basel

European Center Of Pharmaceutical Medicine · Basel, Switzerland

Oct 2000 - Jun 2006

Philipp's University Marburg

Medicine · Marburg, Germany

Certifications & licenses

Licence To Practise Medicine (Approbation)

Statistics

Experience

Total positions 7

Experience in Pharmaceutical 20 y

Avg length 3 y 6 m

Longest experience 5 y 2 m

Global Experience

Countries worked in 2 (Germany, France)

Primary country Germany

Expertise

Recent roles Director Pharmacovigilance, Global QPPV, Head of Pharmacovigilance, EU QPPV, Head of Pharmacovigilance, EU-QPPV

Main industries Pharmaceutical, Healthcare

Main business areas Quality Assurance, Research and Development, Project Management

Qualifications

Certifications earned 1

Profile

Created

March 2026

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Philipp based?

Philipp is based in Frankfurt am Main, Germany.

What languages does Philipp speak?

Philipp speaks the following languages: German (Native), English (Advanced), French (Advanced).

How many years of experience does Philipp have?

Philipp has at least 20 years of experience. During this time, Philipp has worked in at least 7 different roles and for 4 different companies. The average length of individual experience is 3 years and 10 months. Note that Philipp may not have shared all experience and actually has more experience.

What roles would Philipp be best suited for?

Based on recent experience, Philipp would be well-suited for roles such as: Director Pharmacovigilance, Global QPPV, Head of Pharmacovigilance, EU QPPV, Head of Pharmacovigilance, EU-QPPV.

What is Philipp's latest experience?

Philipp's most recent position is Director Pharmacovigilance, Global QPPV at Navitas Life Sciences.

What companies has Philipp worked for in recent years?

In recent years, Philipp has worked for Navitas Life Sciences.

Which industries is Philipp most experienced in?

Philipp is most experienced in industries like Pharmaceutical and Healthcare.

Which business areas is Philipp most experienced in?

Philipp is most experienced in business areas like Quality Assurance, Research and Development, and Project Management. Philipp also has some experience in Marketing.

Which industries has Philipp worked in recently?

Philipp has recently worked in industries like Pharmaceutical.

Which business areas has Philipp worked in recently?

Philipp has recently worked in business areas like Project Management, Quality Assurance, and Research and Development.

What is Philipp's education?

Philipp attended University Of Basel for European Center Of Pharmaceutical Medicine.

Does Philipp have any certificates?

Philipp has 1 certificate: Licence To Practise Medicine (Approbation).

What is the availability of Philipp?

Philipp is immediately available for suitable projects.

What is the rate of Philipp?

Philipp's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.