Senior Specialist, Regulatory & PV Network

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Job Overview

The position of Senior Specialist, Regulatory & PV Network at Ergomed is crucial within the pharmaceutical industry, focusing on the regulatory landscape and pharmacovigilance (PV). This role requires a deep understanding of regulatory requirements and effective project management skills, making it ideal for individuals dedicated to influencing healthcare outcomes. The Senior Specialist will primarily develop and guide regulatory strategies, ensuring that all regulatory deliverables are met according to the established plans, while also acting as a liaison among various stakeholders.

Key Responsibilities

The role entails a variety of important tasks, showcasing the dynamic nature of working within regulatory affairs:

1. Act as Local Contact Person for Pharmacovigilance (PV): Manage PV activities within the designated country, ensuring compliance with local regulations.

2. Leadership and Coordination: Oversee projects of medium to high complexity, ensuring effective coordination and management of regulatory deliverables. Key responsibilities include driving teams to meet targets and complying with protocols, trackers, and templates.

3. Strategy Development: Collaborate with senior team members to develop and implement project management plans, joint operating procedures, and essential documents relevant to the project execution.

4. Risk Management: Identify and mitigate potential risks by employing preventive strategies, thus assuring the quality and compliance of regulatory deliverables.

5. Team Oversight: Monitor the workload of all team members involved in project deliverables, ensuring clarity of tasks, compliance with budgetary constraints, and timelines.

6. Client Interaction: Prepare invoices for clients, review and approve vendors' project invoices, ensuring meticulous financial management throughout the project lifecycle.

7. Mentorship: Provide training, coaching, and mentoring for junior staff, fostering professional development within the team.

8. Regulatory Intelligence Maintenance: Maintain a comprehensive regulatory intelligence database, disseminate updates on legislative changes, and support teams in audit preparations.

9. Collaboration with Internal and External Contacts: Build robust working relationships across different functional areas and with external partners, clients, and regulatory bodies to facilitate seamless operations.

10. Performance Tracking: Monitor and evaluate key performance indicators (KPIs) of local contact persons (LCPs), preparing monthly reports to assess efficacy and compliance.

Required Skills and Qualifications

To excel in this position, candidates should possess the following qualifications and skills:

• Bachelor's Degree: A degree in Chemistry, Life Sciences, Nursing, or a related field is preferred.
• Industry Experience: Strong background in regulatory affairs, ideally within the pharmaceutical or CRO environment.
• Regulatory Knowledge: Comprehensive understanding of ICH GCP, GVP, and national regulations relevant to the territories of competency.
• Language Proficiency: Fluency in English, both written and verbal is essential., alongside proficiency in the official language of the host country for local compliance and interactions.
• Project Management Skills: Excellent organizational and planning skills, with the ability to manage competing priorities in a fast-paced environment.
• Interpersonal Skills: Strong communication abilities and the capacity to build professional relationships are critical for success in this collaborative role.

Salary Information

While the job listing does not specify a salary, positions in regulatory affairs typically offer competitive salaries aligned with experience and industry standards. Job seekers should anticipate a pay range that reflects their qualifications and the level of responsibility within the organization.

Company Culture and Values

Ergomed is committed to fostering a workplace culture that prioritizes diversity, equity, and inclusion. They emphasize respect for individual contributions, which are seen as vital to achieving their mission of improving patients' lives. Benefits offered include:

• Career Development Opportunities: Access to training and professional growth pathways that allow for career advancement.
• Supportive Environment: A friendly workplace where team collaboration and open communication are encouraged.
• Global Workforce: Work with a diverse team of professionals from various geographical locations, using English as the primary language of communication.

Conclusion

The Senior Specialist position at Ergomed offers a unique opportunity for regulatory and pharmacovigilance professionals to contribute significantly to the health sector while being part of a reputable organization. With training programs and a commitment to employee well-being, Ergomed is inviting applications from qualified individuals eager to make a difference in the regulatory landscape of pharmacovigilance. Interested candidates should prepare a thoughtful application that reflects their capabilities and enthusiasm for the role.

This job offer was originally published on himalayas.app