Senior Pharmacovigilance Manager
vor 6 Monaten
**Vacancy Name**
- Senior Pharmacovigilance Manager
**Location of Work**
- Linz, Austria
**Employment Type**
- Full Time Employee
**Our mission**
At Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between performance, value, and a quality customer experience. We are here to support you every step of the way.
- **Our brand promise**
We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.- **Remarkable service**
A seamless, personal process designed around you and your needs.
- ** Trusted performance**
Our product family is the result of years of experience championing surgeons and listening to their expertise.
- ** Outstanding value**
No matter the surgical specialty, we deliver quality products for all markets.
**Our people promise**
Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.
- **Job Purpose Summary**
The Senior Pharmacovigilance Manager is a pivotal role within our organization, responsible for overseeing and managing all aspects of pharmacovigilance activities at the Linz, Austria site. With a deep understanding of regulatory requirements and guidelines, particularly the Good Pharmacovigilance Practices (GVP), this role ensures the safety and effectiveness of our pharmaceutical products. The Senior Pharmacovigilance Manager plays a critical role in safeguarding public health and maintaining compliance with regulatory standards.
- **What you will do**
- Establish and maintain the local pharmacovigilance system at the site, ensuring compliance with Good Vigilance Practices (GVP) guidelines.
- Develop and update local pharmacovigilance standard operating procedures (SOPs) and working instructions (WIs). Implement global pharmacovigilance SOPs on local level.
- Act as the main point of contact for regulatory authorities, partners, and internal departments regarding pharmacovigilance-related inquiries.
- Collaborate with distribution partners and contract manufacturers to create and maintain pharmacovigilance contracts.
- Plan and conduct external pharmacovigilance audits at distribution partners to ensure compliance with pharmacovigilance requirements.
- Participate in pharmacovigilance inspections and audits conducted by Competent Authorities (CAs), Customers or global functions.
- Manage Corrective and Preventive Actions (CAPA) related to pharmacovigilance processes.
- Develop and deliver pharmacovigilance training programs for employees.
- Capture and follow-up on adverse event reports, ensuring timely and accurate reporting to regulatory authorities.
- Evaluate the results of weekly literature searches to identify and assess relevant safety information.
- Review Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) to assess the safety profile of our products.
**What you will need (job requirements)**
- Bachelor's degree in Pharmacy, Life Sciences, or a related field.
- Minimum of 5 years of experience in pharmacovigilance, including knowledge of regulatory requirements and guidelines, particularly the Good Pharmacovigilance Practices (GVP) guidelines.
- Strong understanding of pharmacovigilance processes and systems.
- Excellent organizational and project management skills.
- Ability to effectively collaborate with internal and external stakeholders.
- Strong attention to detail and accuracy in data management.
- Excellent communication skills, both written and verbal.
- German speaking a plus.
- Proficiency in using pharmacovigilance databases and software.
**What we value**
- **Customer First** - We deliver extraordinary experiences.
- ** Accountability** - We do what we say.
- ** Integrity** - We do what is right.
- ** Inspired** - We love what we do.
- ** One Global Team** -We before me, always.
- **_Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics._
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