Quality and Compliance Training Specialist

7 meses atrás

Lisboa, Portugal Ergomed Tempo inteiro

**Company Description**
Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia

Our company allows for employee visibility (you have a voice) creative contribution and realistic career development.

We have nourished a true international culture here at Ergomed.

We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.
**Job Description** Overview**:
**Responsibilities**:

- Design and deliver engaging and interactive training materials, including e-learning modules, workshops, seminars, and job aids, to promote understanding and compliance with regulatory requirements, industry standards, and company policies.
- Ensure training content aligns with relevant regulations and guidelines, such as ICH-GCP, FDA regulations, EMA guidelines, and other international standards, and update materials as needed to reflect changes.
- Monitor and track employee participation and completion of training programs, and maintain accurate records of training activities for audit and compliance purposes.
- Collaborate with Subject Matter Experts and Heads of Departments, to ensure alignment and consistency in training efforts across the organization.
- Conduct assessments and evaluations to measure the effectiveness of training programs and identify areas for improvement, and incorporate feedback from participants to enhance the learning experience.
- Stay informed about changes and updates to regulations, guidelines, and industry best practices in pharmacovigilance and clinical research, and communicate updates to stakeholders as necessary.

**Qualifications**
- Bachelor's degree in a relevant scientific discipline such as pharmacy, life sciences, or a related field (Master's degree preferred).
- Minimum of 2 years of experience in pharmacovigilance, clinical research, quality assurance, or a related field, with a focus on training and education.
- Strong knowledge of regulatory requirements and guidelines governing pharmacovigilance and clinical research, including ICH-GCP, FDA regulations, EMA guidelines, and other international standards.
- Excellent communication and presentation skills, with the ability to effectively convey complex information to diverse audiences.
- Detail-oriented with strong organizational and project management skills, including the ability to manage multiple priorities and meet deadlines.
- Experience with GxP audits and inspections a plus
- Certifications such as RAC (Regulatory Affairs Certification), CCRP (Certified Clinical Research Professional), Certified Quality Auditor (CQA) or Certified Compliance and Ethics Professional (CCEP) are a plus.

**Additional Information**
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join

Quality

Integrity & Trust

Drive & Passion

Agility & Responsiveness

Belonging

Collaborative Partnerships

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