Pharmacovigilance (PV) Policy and Governance Leader (m/w) Southwestern Baden-Wuerttemberg


Our client is a leading global research-based pharmaceutical company with highly innovative medicines and a strong development pipeline. The company is steering central elements of the technical quality control for the whole European region.

 - Location: Southwestern Baden-Wuerttemberg


Main tasks:

The Governance, Policy and QPPV Office Group supports the QPPV in fulfilling a number of roles and responsibilities related to oversight of the PV system as outlined in the EU PV regulations.

That implies in detail:

  • As a forward thinking PV expert with the ability to work strategically and drive change, a PV (Pharmacogivilance) Policy and Governance Leader will lead and provide direction and expertise regarding assessment of and compliance with PV legislation
  • You will participate in inspection readiness programs/projects and have oversight of relevant improvement initiatives as necessary.
  • You will build solid working relationships with other functions and departments (e.g. Drug Safety, Regulatory, Quality Assurance, Medical Affairs, Commercial Organization and Affiliates) to identify and address inspection readiness concerns.
  • By providing strategic direction on the PSMF (Pharmacovigilance System Master File) content and approaches, you will be responsible for ensuring the consistency and accuracy of this business critical document, and you will support Data Delivery responsibles in monitoring compliance with the data described in the PSMF.
  • As a PV subject matter expert, you will provide input into corrective and preventative action plans (CAPAs), as needed, in collaboration with Global Process Owners and Quality Excellence colleagues and you will maintain oversight of inspection, audit and deviation CAPAs and trends related to the PV System in collaboration with the GVP Council.
  • Your expert input will be required in designing PV processes, procedures and tools as needed to support company positions and to ensure adherence to regulatory requirements and expectations.
  • You will work as a member of the QPPV Office team, assisting colleagues with activities both within the group and across other groups and functions as necessary.
  • You will also interact externally with other PV experts and groups to enhance the companys reputation and influence in the PV arena.



To be successful within this role you should have a Life Science Degree (e.g. BSc Pharmacology, BSc Biology, BSc Neuroscience, etc.) or Health Care Professional Degree (e.g. PharmD, BPharm, RN, BSN, PA, NP).

Along with substantial pharmaceutical experience, preferably in all areas of PV, you will be able to demonstrate experience of leading global pharmacovigilance teams or high profile projects.

You will also bring an expert knowledge and understanding of pharmacovigilance regulatory requirements and general regulatory expectations.


With expertise in designing and driving the implementation of complex, cross-functional initiatives, you will have the ability to make good business decisions and exercise sound judgment.


You will bring excellent planning and organisation skills to the role and you will set high standards with great attention to detail. With the ability to operate objectively and independently, you must be confident in building strong sustainable relationships with internal and external stakeholders.


As a creative problem solver with excellent analytical and systems thinking, you will also foster a culture of continuous improvement.



From your beginning with our client, a motivated team will welcome and support you. Beside exciting responsibilities and challenges, numerous opportunities for personal development, flexible work hours, attractive compensation packages and special family assistance programs are available.


Contact person:

Dr. med. Monika Kässner-Sohn
Senior Partner
TROCKLE Unternehmensberatung
Neumannstr. 17
D- 40235 Düsseldorf
Tel.: + 49 (0)211/95756914