Philipp (Dr) Hofmann-Director Pharmacovigilance, Global QPPV
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Experience
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
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
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
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
Safety Officer Germany, Deputy EU QPPV
Fresenius Kabi Deutschland
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
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.
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.
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
Education
University Of Basel
European Center Of Pharmaceutical Medicine · Basel, Switzerland
Philipp's University Marburg
Medicine · Marburg, Germany
Certifications & licenses
Licence To Practise Medicine (Approbation)
Statistics
Experience
Global experience
Expertise
Qualifications
Profile
Frequently asked questions
Have questions? Find more information here.
Philipp is based in Frankfurt am Main, Germany.
Philipp speaks the following languages: German (Native), English (Advanced), French (Advanced).
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.
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.
Philipp's most recent position is Director Pharmacovigilance, Global QPPV at Navitas Life Sciences.
In recent years, Philipp has worked for Navitas Life Sciences.
Philipp is most experienced in industries like Pharmaceutical and Healthcare.
Philipp is most experienced in business areas like Quality Assurance, Research and Development, and Project Management. Philipp also has some experience in Marketing.
Philipp has recently worked in industries like Pharmaceutical.
Philipp has recently worked in business areas like Project Management, Quality Assurance, and Research and Development.
Philipp attended University Of Basel for European Center Of Pharmaceutical Medicine.
Philipp has 1 certificate: Licence To Practise Medicine (Approbation).
The availability of Philipp needs to be confirmed.
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Calculated based on our freelancers’ daily rates as of 25 Aug 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
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