Pharmacovigilance Auditor (m/w/d)

Company : Midas Pharma Gmbh

Job Description - Pharmacovigilance Auditor (m/w/d)

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

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)
Very good command of English and German
Strong project management and communication skills

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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Pharmacovigilance Auditor (m/w/d)

Job Description - Pharmacovigilance Auditor (m/w/d)

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