Senior Specialist, Regulatory & PV Network

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🔥 0 minutes ago

🌐 Serbia, Romania – Remote

🇷🇸 Serbia – Remote 🇷🇴 Romania – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 17%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Act as Local Contact Person for Pharmacovigilance for the designated country • Lead and provide functional representation for medium/high-complexity projects • Coordinate and manage regulatory deliverables and drive teams to meet targets and 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 through preventive measures • Problem solve and support resolution of performance issues or delivery failures • Collect, review, track and maintain LCP CVs, job descriptions, training records, contact details and monthly reports • Ensure correct training assignment and compliance by LCPs • Communicate project tasks and allocated time to team members • Monitor project budgets, hours spent versus budgeted, and escalate out-of-scope issues • Support proposal development and budgets and represent the department in business development meetings • Prepare client invoices and review/approve vendor 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 • Disseminate pertinent regulatory changes in a timely manner • 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

• Remote work availability • Flexible work environment • Growth opportunities • Collaborative team environment • Work with global teams across Europe, North America, South America, Asia and Australia • Professional development through training, coaching and mentoring • Passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting