Pharmacovigilance Auditor (all genders)

Your mission

As Pharmacovigilance Auditor (all genders), you maintain and improve the PV related quality management system in accordance with Good Pharmacovigilance Practice (GVP) guidelines. Working with internal and external partners, you will ensure regulatory compliance and promote a robust culture of vigilance and safety.

Your tasks:

• Planning, conducting and following-up of pharmacovigilance audits and inspections, including supervision and training of external service providers and consultants (for audits), ensuring compliance with PV relevant and regulatory requirements company standards .
• Oversee and follow-up of corrective and preventive actions (CAPA) and PV specific deviations (internal or external).
• Maintain accurate QA GVP documentation: Ensure that all QA documentation related to PV - including audit reports and CAPA plans - is accurate, up to date and readily accessible.
• Ensure PV systems and processes comply with regulatory standards and identify areas for improvement.
• PV quality performance and compliance monitoring
• PV SOPs preparation and update, PV training
• Collaborate with QM, IT and vendors to address system gaps
• Compliance monitoring and evaluation of potential drug risk reports

Your profile

• At least 3 years of experience in pharmacovigilance
• Knowledge of pharmacovigilance quality assurance
• Proven experience in managing pharmacovigilance audit programs and teams, including conduct and supervision of pharmacovigilance audits. Experience with regulatory inspections preferred.
• Degree in life sciences, pharmacy or related field
• In-depth understanding of global pharmacovigilance regulations and guidelines, including GVP and ICH requirements
• Experience with PV systems and tools, including safety databases and reporting systems. (e.g. Argus Safety, Trackwise, EVDAS)
• Strong project management and communication skills

Our Offer

• Midas Pharma is a well-established and renowned family business that offers you a personal and appreciative working atmosphere in addition to the security of over 30 years of business
• Our workplaces are not open-plan offices, but personal offices where you can also retreat from time to time, equipped with the latest technology and ergonomic office furniture
• Our organization enables you to make quick decisions - a key factor of our success
• Due to our flat hierarchies, there is a very close interaction at Midas - personal and professional - it is not uncommon for management to be involved in interdisciplinary projects
• We are looking for you as a personality and want you to contribute authentically - in turn, we encourage this by giving you great freedom for creativity and independence
• At Midas, all paths to personal and professional development are open to you - various support programs as well as assignments abroad are just a few possibilities

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About us

Where people make the difference
Everyday work at Midas Pharma is diverse and challenging. This is what motivates and inspires us. That is also reflected in the people who work here: Our employees make the difference.
We know: We accomplish more as a team. This is the only way to transfer knowledge and create the synergies that make us so successful as a company. That's why teamwork is a key factor for us. For our employees, this means that there is scope to make a difference and take on responsibility. Commitment, expertise and creativity meet flat hierarchies, short decision-making processes and highly competent team members. An inspiring environment that motivates you to go the extra mile. In the work for our customers and in the development of your own skills.