Deputy to The Qualified Person for

vor 2 Monaten

Nuernberg, Deutschland ITM Isotope Technologies Munich SE Vollzeit

**Your Role**:

- Fulfill the roles outlined in the European Medicines Agency Guideline on good pharmacovigilance practices (GVP) Module I and be available on a 24-hour basis during absence of the EU QPPV
- Lead the QPPV Office (~3 FTEs by end of 2023)
- Participate in company Signal Management activities; contribute to the identification and evaluation of safety signals from all available sources
- Participate in the timely planning, execution, submission, implementation and maintenance of RMPs, periodic aggregate safety reports (PSURs/PBRERs) and ad hoc safety reports
- Participate in the creation of response documents to Regulatory Authorities in cooperation with other colleagues as appropriate
- Ensure compliance with European PV Legislation and European Regulations and maintaining the company’s Pharmacovigilance system
- Ensure maintenance of the pharmacovigilance system master file (PSMF)
- Maintain a robust Pharmacovigilance compliance programme, company policies and Standard Operating Procedures (SOPs)
- Build good working relationships with other departments, both globally and at European level, to ensure all PV-related activities are fully understood and carried out in timely manner
- Assist in the implementation of compliance standards and facilitate the regular collection of compliance metrics as required
- Collaborate with relevant departments to maintain PV agreements, contracts, Safety Data Exchange Agreements (SDEAs), pre-audit questionnaire and data analysis relevant to the company’s quality compliance programme
- Maintain inspection readiness for GPvP audits and inspections; take part in the preparation and help conduct Pharmacovigilance inspections/ audits and contribute to GxP inspections/ audits, as necessary; support timely execution and submission of responses to inspections/ audits findings; maintain inspection/audit related documentation and PSMF files containing audit reports
- Have oversight and, as needed, deliver Pharmacovigilance training for European employees, ensuring company training and training attendance log is kept and training folders are maintained by European PV personnel
- Assist in the management of PV activities at affiliate level, in line with corporate procedures

**What we are looking for**:

- Reside and operate in a country of the EU or the EEA (France or Germany)
- MD, Pharm D or equivalent
- Minimum 8 years’ experience in pharmacovigilance in an industry setting
- Demonstrated knowledge of EU requirements concerning pharmacovigilance and risk management
- Previous experience in a similar role of minimum 4 years
- Experience working in a cross functional team within a matrixed environment
- Advanced knowledge of regulations governing Pharmacovigilance in the pharmaceutical industry and Research & Development processes in Europe and globally
- Proven expertise in Pharmacovigilance, including risk management - understanding, identifying, mitigating and communicating risks
- Excellent analytical, problem-solving, strategic planning, and interpersonal skills
- Effective multi-tasking skills, applied in different and complex assignments
- Open to changes, suggestions and innovations, continuously on the look-out for work processes' improvements
- Proven ability to:

- Lead teams
- Work both independently and collaboratively and use own initiative
- Communicate effectively both locally and globally, internally and externally
- Collaborate with technical teams and deliver high-quality results within established timelines
- Thrive in a fast-paced environment while providing appropriate attention to details

**What we offer**:

- A modern workplace and exciting opportunities in an evolving and fast growing company
- Challenging and varied projects in interdisciplinary, multicultural and highly professional teams
- A collegial corporate culture and short communication channels
- Flexible working hours with an attractive salary package and diverse corporate benefits

At ITM, we work together towards one common goal - the benefit of our patients. This is what drives us, every day. This is what we are passionate about. For this we create opportunities that are as unique as our team. We encourage diversity and inclusion - the input of our multi-cultural employees makes us who we are.

Only together we can contribute to significantly improving the outcome and quality of life of cancer patients worldwide and to giving better answers than “maybe”.

Does this sound like you? Are you interested in shaping the future of ITM and joining one of our highly committed teams in an innovative work environment?

Then send us your detailed CV including earliest start date and salary expectations. The position is intended for the ITM Oncologics GmbH, a company of the ITM group. Applications are accepted either in German or English language.

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