Senior Specialist, Regulatory & PV Network

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🔥 0 minutes ago

🇧🇦 Bosnia and Herzegovina – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 16%

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Develop regulatory strategy based on regulatory requirements • Drive regulatory and pharmacovigilance deliverables based on established plans • Act as Local Contact Person for Pharmacovigilance for the designated country • Lead and represent medium/high-complexity projects • Coordinate and manage regulatory deliverables and drive teams to meet targets and comply with procedures • Develop strategy and manage project setup activities, including Project Management Plans, joint operating procedures, POAs and core documents • Provide strategic input to internal and external customers • Identify and address risks by implementing preventive measures • Problem solve and support resolution of performance issues or delivery failures • Collect, review, track and maintain LCP records, including CVs, job descriptions, training records, contact details and monthly reports • Ensure correct training assignment and compliance by LCPs • Monitor project budgets, hours spent versus budgeted, and identify and escalate out-of-scope work • Support proposal development and budgets and represent the department in business development meetings • Prepare client invoices and review/approve vendors’ project invoices • Train, coach and mentor junior staff • Foster professional relationships with internal and external contacts locally and internationally • Monitor changing regulatory legislative requirements and maintain the regulatory intelligence database • Participate in or support audit/inspection preparation • Track LCP key performance indicators and prepare monthly summary reports • Provide vendor performance feedback • Contribute to department/company initiatives and design or review SOPs, working practices and guidance

🎯 Requirements

• Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience • Strong experience within pharmaceutical or CRO industry or Regulatory body • Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency • PV training and/or working experience and other educational or professional background as required locally • Fluent in English, both written and verbal • Proficient in the official language of the country in which they are based • Good planning and organizational skills • Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment • Good attention to detail

🏖️ Benefits

• Flexible remote work • Growth opportunities • Collaborative and supportive team culture • Global work environment • Professional development through training, coaching and mentoring • Opportunity to work with experts in clinical research, pharmacovigilance and quality consulting