As the experts in digestive and metabolic medicine and as a family-owned business with a global presence, we focus on developing and marketing innovative medicines to treat a wide range of gastrointestinal disorders like inflammatory bowel disease or eosinophilic esophagitis as well as hepatobiliary disorders such as primary biliary cholangitis. Our aim: to meaningfully improve therapeutic practice as well as patient health and well-being. We firmly believe that medical progress can only be achieved by working together. That is why we are looking for:

Your tasks

Team management of a group of Global Safety Product Leads including leading, mentoring, and developing a team of Global Safety Product Leads, fostering a culture of compliance and excellence.

Ensuring takeover of the following tasks and responsibilities of the Global Safety Product Leads group:

Global pharmacovigilance product responsibility for the medicinal products
Monitoring of the benefit-risk profile
Signal management: signal detection, signal validation, signal evaluation
Risk management: preparation of risk management plans, supervision of risk minimization measures
Preparation of periodic safety reports
Supervision of interventional and non-interventional studies, as well as other data collection activities including preparation and review of study-specific documents

Supporting the Head of Global Safety / EU/UK QPPV / Graduated Plan Officer in the fulfillment of pharmacovigilance obligations, including

Collection, systematic documentation and evaluation of all necessary information in connection with indications of drug risks, in particular adverse drug reactions, interactions and contraindications, as well as indications of quality defects, misuse, long-term use, abuse or counterfeit drugs
Medical/scientific assessment of drug risks and their documentation, taking into account the statutory reporting obligations to the competent authorities
Passing on necessary information to pharmacovigilance departments at service providers, licensees/licensors, distribution partners and affiliates within the framework of contractual pharmacovigilance agreements
Support with periodic reconciliations with partners, subsidiaries and internal departments
Support in the preparation of pharmacovigilance agreements
Support in creation and maintenance of pharmacovigilance system master file (PSMF)
Overview of the pharmacovigilance system including the establishment of suitable key performance indicators to measure quality
Ensuring the required quality of pharmacovigilance data
Support with GVP inspections and audits
Creation and maintenance of standard operating procedures (SOPs) for pharmacovigilance
Performance of pharmacovigilance trainings for employees of Dr. Falk Pharma GmbH, affiliates and license partners

Responsibility as Deputy Graduated Plan Officer according to §63a AMG which includes the following in absence of the Graduated Plan Officer:

Ensuring an adequate quality management system to fulfill all relevant pharmacovigilance obligations of Dr. Falk Pharma GmbH by establishing suitable working methods and processes as well as procedural instructions for the quality assurance of results
Collection and systematic documentation of reports on suspected cases of possible drug risks before and after receiving marketing authorization, from spontaneous reports, as part of post-marketing surveillance, from publications in the specialist literature and relevant databases. This includes the active and regular review of specialist literature and relevant databases with regard to published suspected cases of adverse drug reactions
Fulfillment of all statutory notification and reporting obligations with regard to possible drug risks
Evaluation of potential drug risks with simultaneous continuous updating of the benefit-risk assessment, if necessary with the involvement of a consultant human physician
Coordination of risk prevention measures as part of the action plan
Updating the action plan and its monitoring and compliance
Informing the competent authority(ies) about quality defects that could lead to a recall or an unusual restriction of distribution
Informing the competent authority(ies) of any suspicion of falsification of medicinal products or active substances
Coordination of a step-by-step plan procedure with the competent federal authority, the supervisory authorities and, if applicable, competent associations such as BPI (German Pharmaceutical Industry Association), BAH (German Association of Pharmaceutical Manufacturers) and VfA (Association of Research-Based Pharmaceutical Companies)
Ensuring that the persons responsible for pharmacovigilance at licensees/licensors, sales partners and subsidiaries are informed about identified drug risks
Informing and advising affected company divisions

Responsibility as Deputy EU/UK QPPV which includes the following in absence of the EU/UK QPPV:

Creation and maintenance of the Pharmacovigilance System Master File (PSMF) of Dr. Falk Pharma GmbH in accordance with the requirements of EU/UK legislation
Overview of the entire pharmacovigilance system including the establishment of suitable parameters for measuring quality (key performance indicators)
Ensuring the required quality of all pharmacovigilance data
Collection and reporting of suspected adverse drug reactions within the reporting deadlines specified in EU/UK legislation
Transmission of information in connection with the benefit-risk assessment of Dr. Falk Pharma GmbH's medicinal products to the responsible EU/UK authorities
Overview of periodic reconciliations with partners and subsidiaries as well as internal reconciliations with the Quality and Medical Scientific Affairs departments
Carrying out a continuous assessment of the benefit-risk profile as part of signal management
Conducting PV training for employees of Dr. Falk Pharma GmbH, sales partners and subsidiaries
Preparation of periodic safety reports (PSUR/DSUR)
Preparation of risk management plans including the coordination of risk-minimizing measures
Approval and release of PASS protocols
Support and advice in the preparation of regulatory submissions
Contact person for the competent EU/UK authorities on a 24/7 basis
Contact person for GVP inspections
Supervision of interventional and non-interventional studies, as well as other data collection activities including preparation and review of study-specific documents

Your qualification

Successfully completed degree in pharmacy or human medicine
Several years of professional experience in the field of pharmacovigilance
Several years of management experience
Strong team player and excellent communication skills
Very careful and accurate way of working
High degree of reliability
Very good written and spoken German and English skills

Your benefits

Supportive, respectful and appreciative work atmosphere in a small, dedicated team
Diverse learning culture and individual development opportunities
International and growing family business with short decision-making processes, financial independence and long-term perspective
New work, flexible working hours and mobile working
Wide range of benefits (free beverages, health and sports benefits, canteen, JobRad)
Comprehensive onboarding and mentoring program

If you have any questions, please do not hesitate to contact Sabine Aicher at personal@drfalkpharma.de or call 0761 1514-253. We look forward to receiving your application via our online portal.

Online bewerben