Senior Specialist, Regulatory & PV Network

Ergomed is seeking a Senior Specialist, Regulatory & PV Network to join our global team. In this role, you will develop regulatory strategies, drive pharmacovigilance deliverables, and serve as a key liaison between internal teams, clients, and regulatory authorities to ensure compliance and project success.

Key responsibilities

• Act as the Local Contact Person for Pharmacovigilance for your designated country.
• Lead regulatory projects of medium to high complexity, ensuring effective coordination and adherence to project timelines and quality standards.
• Develop project strategies, manage setup activities, and provide strategic input to internal and external stakeholders.
• Identify and mitigate potential risks, ensuring proactive problem-solving and performance management.
• Provide training, coaching, and mentoring to junior staff members while contributing to departmental initiatives and SOP development.

Requirements

• Bachelor's degree in Chemistry, Life Sciences, Nursing, or equivalent professional experience.
• Strong experience within the pharmaceutical or CRO industry, or a regulatory body.
• Solid knowledge of ICH GCP, GVP, and national regulations relevant to your territory.
• Proven experience in pharmacovigilance and regulatory affairs.
• Fluency in English and proficiency in the official language of your base country.
• Excellent organizational, planning, and interpersonal skills with high attention to detail.

What we offer

• The opportunity to make a meaningful difference in patient safety and pharmaceutical development.
• A collaborative, diverse, and inclusive work environment that values integrity, agility, and partnership.
• A culture focused on professional growth, kindness, and global teamwork.
• The chance to work on impactful projects with a global reach in a purpose-driven organization.