Consultant Pharmacovigilance (PV)

EXTEDO; Ottobrunn; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

EXTEDO is seeking a dedicated Pharmacovigilance Consultant to support customers in implementing, validating, and operating drug safety processes and solutions. You will advise on regulatory topics, harmonize processes, and help clients achieve compliance and efficiency across global projects.

The role combines regulatory expertise, business consulting, and solution knowledge in a dynamic, international environment.

Qualifikationen

• Experience in pharmacovigilance, drug safety, regulatory affairs, safety operations, or related consulting activities.
• Knowledge of global pharmacovigilance regulations and guidelines, including EMA, FDA, ICH, and GVP requirements.
• Strong analytical, communication, presentation, and customer-facing consulting skills.
• Ability to work effectively with customers, cross-functional teams, and internal stakeholders in an international environment.

Aufgaben

• Analyze customer pharmacovigilance processes, requirements, and challenges, and provide recommendations aligned with industry best practices and regulatory requirements.
• Support the implementation, configuration, validation, and adoption of drug safety solutions.
• Conduct customer workshops, requirements-gathering sessions, training activities, and business process assessments.
• Advise customers on pharmacovigilance regulations, compliance topics, process harmonization, and operational improvements.
• Contribute to presales activities, customer demonstrations, proposals, Statements of Work, and solution presentations related to pharmacovigilance projects.
• Cross-operate between Product Management, Development, Professional Services, and Customer Support to address customer requirements, enhancement requests, and solution improvements.
• Provide second- and third-level functional support for customer issues and service requests including the investigation, analysis, documentation, and resolution of customer support tickets related to pharmacovigilance processes and solutions

Kenntnisse

Pharmacovigilance

Drug safety

Regulatory affairs

Consulting skills

Cross-functional collaboration

Customer-facing

Ausbildung

Degree in Life Sciences, Pharmacy, Medicine or related

Jobbeschreibung

Imagine a world where life-saving medicines and vaccines reach those who need them most, faster and more safely. At EXTEDO, this is not just a vision - it’s our daily mission.

We are driven by the profound responsibility to ensure that every treatment, every cure, and every vaccine reaches patients without unnecessary delays. Our work empowers health authorities and pharmaceutical companies around the globe to navigate the complex regulatory landscape with confidence, knowing they have a trusted partner in the life science industry for managing and streamlining regulated information at every step of the pharmaceutical product lifecycle. With over 25 years of innovation, 100+ employees, and 20+ nationalities, EXTEDO stands as a leader in Regulatory Information Management (RIM).

We are looking for someone, who supports customers in the implementation, validation, and operation of pharmacovigilance and drug safety processes and solutions. The role combines regulatory expertise, business consulting, and solution knowledge to help customers achieve compliance, operational efficiency, and effective use of EXTEDO solutions and services.

Job Description

• Analyze customer pharmacovigilance processes, requirements, and challenges, and provide recommendations aligned with industry best practices and regulatory requirements
• Support the implementation, configuration, validation, and adoption of drug safety solutions
• Conduct customer workshops, requirements-gathering sessions, training activities, and business process assessments
• Advise customers on pharmacovigilance regulations, compliance topics, process harmonization, and operational improvements
• Contribute to presales activities, customer demonstrations, proposals, Statements of Work, and solution presentations related to pharmacovigilance projects
• Cross-operate between Product Management, Development, Professional Services, and Customer Support to address customer requirements, enhancement requests, and solution improvements
• Provide second- and third-level functional support for customer issues and service requestsincluding the investigation, analysis, documentation, and resolution of customer support tickets related to pharmacovigilance processes and solutions

Qualifications

• Degree in Life Sciences, Pharmacy, Medicine, Pharmacovigilance, Regulatory Affairs, or a related discipline
• Experience in pharmacovigilance, drug safety, regulatory affairs, safety operations, or related consulting activities
• Knowledge of global pharmacovigilance regulations and guidelines, including EMA, FDA, ICH, and GVP requirements
• Strong understanding of pharmacovigilance business processes such as case management, safety reporting, and compliance activities
• Excellent analytical, communication, presentation, and customer-facing consulting skills
• Ability to work effectively with customers, cross-functional teams, and internal stakeholders in an international environment

Additional Information

Modern Working Conditions: Welcome to a relaxed and friendly work environment with an open-door policy. We understand the importance of work-life balance, offering flexible working arrangements, including the option to work remotely for up to 20 days per year within the EU. Our height-adjustable desks also ensure ergonomic working conditions.

Personal & Professional Growth: With a comprehensive onboarding and training program, you will feel like part of the team from day one. We invest in your future with continuous learning and development opportunities, empowering you to grow your career while making a real difference and enjoying a collaborative environment.

Passionate About People: You’ll collaborate with a diverse team of experts from more than 20 nationalities who are united by a shared passion for innovation and excellence in healthcare. Join us in fostering diversity and equality for all! Be part of a team that values inclusivity and celebrates individuality. Together, let's create an environment where your ideas are heard and everyone can thrive.

Wellbeing included! Enjoy regular company and team events, a canteen allowance, 30 days of vacation for a 5-day work week and a comprehensive company pension scheme, a subsidy for your public transport ticket DB Jobticket, EGYM Wellpass offer, bike leasing.

Disclosure requirements pertaining to the collection of your personal data:

Responsible for processing the information provided in your application is the company specified in the job advertisement, with its registered office as indicated. The company processes your data for the purpose of establishing an employment relationship on the basis of Art. 6 (1) b GDPR / Section 26 (1) sentence 1 BDSG.

The retention period for your data is determined by the statutory time limits applicable in the respective country, beginning upon completion of the recruitment process. You can find these here .

You can contact the company’s Data Protection Officer at the above-mentioned postal address.

Further information on data protection and your rights can be found here .