QbD Groupteam offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, ATMP and Medical Devices/IVD. We are always looking for the next QbD’er inPharmacovigilance.
What do we expect from you as a JuniorDrug Safety Officer ?
Employees belonging to this professional category perform clearly established functions, with specific instructions and a high degree of organizational dependence.
The general responsibilities assigned to this professional category are:
- The performance of tasks and duties of instrumental and highly predictable content in accordance with previously established instructions according to the rules, guidelines or ordinary procedures in regular use in the company, tasks for which they have the direct supervision of the immediate superior.
- Cases management control
- Data entry and quality control of PV cases in post-marketing and clinical trials, or related to medicinal products, medical devices and cosmetics.
- PV Assessment of any case of suspected adverse reaction.
- Direct contact with HCP and patients/consumers.
- Perform any follow up activities required.
- Submission of cases to Eudravigilance, MHRA or any other Competent Authority.
- Perform bibliographic searches in local scientific journals, international journals, MLM service and any other type of search.
- Management of medical information and answer of queries.
- Review and control of Safety Regulatory intelligence
- Review and control of Pharmacovigilance quality system
- Participation in specific events related to their area of work.
Who are we looking for?
- Bachelor's degree in Life Sciences or related
- Master's degree in Pharmacovigilance, Pharmaceutical Industry or related. Desirable.
- High level of English. Desirable
- Advanced informatic skills
- Knowledge of MS Office. Desirable.
Personal skills:
- Good teamwork skills and high learning capacity is considered a plus.
- Participative and proactive in work groups.
- Attention to detail
- Skills and/or experience in the writing of scientific texts. Desirable
- Organization ability and task prioritization.
- Management of bibliographic searches. Desirable
Previous experience:
- Work experience as Trainee and updated knowledge in Quality Assurance for the Pharmaceutical Industry is a plus.
- Bibliographic search and database management. Desirable
- Knowledge in European Good Pharmacovigilance Practices (GVPs).
- Knowledge regarding Eudravigilance requirements for Marketing Authorization
Holders (clients) and the processes with the Health Competent Authorities. Desirable
A true QbD’er can be recognized by the following qualities:
* Resilient : Your strong and positive attitude helps you overcome any challenge
* Hungry for knowledge: You are always open to learning
* No non-sense mentality: you can be straightforward in a respectful way
* Innovative : You are constantly looking for new and better solutions
* (Not too) serious : your job is serious, but you don’t take yourself too serious.
What’s in it for you?
* QbD Group offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.
* Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed.
* As we’re a knowledge-based company, you’re guaranteed to embark on a continuous journey of learning and development.
* Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together
Our promise to you:
* As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
* Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
* In short ... We stand for? JPEG : J oy in P artnership, going for the E xtra mile to G et things done!
Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!
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