Established in 2005, the DLRC Group has developed a deserved reputation for being a leading consultancy, with a wealth of regulatory and scientific knowledge and considerable experience in both leadership and management. The company has recently expanded to include affiliates based in Germany and the US.

Our growing team comprises over 90 qualified professionals with a pharmaceutical and/or regulatory background, as well as over 30 dedicated supporting staff in areas of Business Development, Finance, Business Services and People Practices. We provide services to over 130 organisations, enabling them to achieve their strategic and operational development objectives.

DLRC’s expertise and flexible working approach ensures the provision of a highly motivated team who interact effectively with clients and regulators globally, to support both single issues and long-term commitment to projects.

Senior/Principal Pharmacovigilance Consultant

Germany based preferred | Hybrid & Flexible Working

DLRC is seeking a Senior/Principal Pharmacovigilance (PV) Consultant, based in Germany, to provide strategic pharmacovigilance and regulatory safety expertise to global life science clients. This is a senior, client-facing role suited to an experienced PV professional with strong commercial awareness and the ability to advise confidently across the product lifecycle.

The opportunity

This role combines strategic PV consultancy with operational oversight responsibilities within DLRC/Orphix’s MAH activities. The successful candidate will support clients across development and post-authorisation phases, providing expert guidance on regulatory safety, compliance, lifecycle management, and inspection readiness.

The role also includes pharmacovigilance oversight where DLRC/Orphix acts as a Marketing Authorisation Holder (MAH) on behalf of clients for products that have not entered the EU market. Experience acting as, or deputising for, a Qualified Person for Pharmacovigilance (QPPV) is advantageous but not essential.

Working closely with Regulatory, Quality, and Safety colleagues, the Senior/Principal Consultant will contribute to the ongoing development of DLRC’s pharmacovigilance systems, processes, and internal capabilities.

Key responsibilities:

Strategic and Operational PV Consulting

• Provide strategic and operational pharmacovigilance advice across development and post-authorisation phases.
• Act as a subject matter expert for DSURs, PSURs/PBRERs, Risk Management Plans (RMPs), and Risk Minimisation Measures (RMMs).
• Advise clients on EU, UK, and US pharmacovigilance requirements and regulatory expectations.
• Support clients with PV strategy, lifecycle management, inspections, and compliance remediation activities.
• Conduct pharmacovigilance system audits and advise on CAPAs.
• Contribute to internal training, mentoring, and knowledge-sharing initiatives.
  

Pharmacovigilance Responsibilities (MAH / Orphix)

• Act as the named Sponsor pharmacovigilance contact and escalate PV issues where appropriate.
• Provide oversight of pharmacovigilance vendors and third-party providers.
• Act as PV contact person for audits and inspections.
• Support the writing, review, and maintenance of pharmacovigilance system documentation, including:

Pharmacovigilance System Master File (PSMF)

Pharmacovigilance procedures and agreements

Client-specific PV Standard Operating Procedures

Attend safety review meetings as required

Provide the DLRC QPPV with the necessary information to fulfil their responsibilities

Ensure ongoing compliance with EU and UK pharmacovigilance legislation and guidance

Monitor regulatory changes and communicate relevant updates internally.

Technical Skills

• Extensive pharmacovigilance experience within consultancy, MAH, or sponsor environments.
• Experience working within safety committees and cross-functional teams.
• Senior client-facing experience with the ability to provide strategic regulatory advice.
• Experience overseeing outsourced pharmacovigilance vendors.
• Strong expertise in DSUR, PSUR/PBRER, RMP, and RMM preparation and review.
• Strong understanding of EU and UK GVP requirements and regulations.
• Experience with US pharmacovigilance requirements, including FDA safety reporting obligations.
• Experience supporting inspections and regulatory readiness activities.
• Excellent written and verbal communication skills.
• Experience writing pharmacovigilance documentation and delivering PV training.
  

About you:

• Communicates complex scientific and regulatory concepts clearly and effectively.
• Builds trusted client relationships and provides commercially aware guidance.
• Makes sound decisions independently while managing risk appropriately.
• Works collaboratively across Regulatory, Quality, and Safety functions.
• Manages competing priorities effectively while meeting timelines and client expectations.
• Contributes to mentoring, training, and knowledge sharing across teams.
• Demonstrates a proactive approach to compliance and operational excellence.
• Medical degree (MBBS, MBChB, MD or equivalent) required.

• Germany-based and eligible to work within the EU.
• Fluent in English.
  

Desirable:

• Experience acting as a QPPV or Deputy QPPV.
• Expertise in pharmaceutical science, epidemiology, or biostatistics.
• Experience supporting biotech, orphan-drug, or small-to-mid-size MAH portfolios.
• Experience in Medical Device vigilance.
• Experience in medical information activities.
  

Why join us?

We are a consultancy built on integrity, respect, and accountability. Our people are trusted to take ownership, supported to develop, and encouraged to think commercially.

We bring energy and enthusiasm to our work, collaborating closely with clients and partners to deliver practical, sustainable solutions. With flexible working and strong professional development pathways, we offer an environment where regulatory consultants can build influence, capability, and long-term careers.

We review applications and conduct interviews on a rolling basis, so don’t delay in applying. Our Talent Acquisition team will be in touch with an update once your application has been reviewed.