Associate Director – International PV

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Biomapas

WebsiteLinkedInAll Job Openings

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Biomapas is a comprehensive outsourcing solution provider catering to the global life science sector. The company acts as a strategic partner for biopharmaceutical and medical device companies, offering extensive clinical research services worldwide. Biomapas covers the entire product lifecycle from regulatory compliance to pharmacovigilance and medical information. The company operates across various regions including Europe, CIS, EAEU, MENA, LATAM, and the US, ensuring high-quality, efficient, and cost-effective methodologies to deliver superior service and strategic advantages. With a focus on clinical trials, pharmacovigilance, and regulatory affairs, Biomapas is equipped to navigate complex regulatory environments and manage clinical trial data effectively, contributing to clients' commercial success.

📋 Description

• Join our Pharmacovigilance team as Associate Director International PV. • Responsible for the leadership and oversight of the international PV office. • Ensure compliance with international regulations, guidelines, and internal quality standards. • Oversee and manage a team of EU/UK QPPVs and PV personnel. • Support operational, financial, and client objectives of the sub-department. • Drive process excellence and effective management of PV operational activities. • Influence the performance of the quality system and PV activities. • Oversee sub department forecasting and contribute to budget planning. • Manage PV projects and customer activities, supervising core PV deliverables. • Ensure oversight of the contractual partner safety data exchange agreements. • Oversee inspection/audit strategy, readiness, and finding remediation. • Monitor regulatory changes and ensure PV compliance across assigned projects. • Manage assigned team, set goals, evaluate performance, and support decisions on promotions. • Identify areas for improvement and proactively propose solutions.

🎯 Requirements

• Biologist, Pharmacist, Medical Doctor, or other life science degree • At least 6 years of work experience in PV functions and 1 year of experience in managing PV teams • Team management experience • Excellent knowledge of international regulations (ICH, EU GVP Modules, UK guidelines, FDA) • Experience in PV Medical writing and Project management skills • Demonstrated ability to accurately and effectively evaluate, interpret and present safety data and to interpret and apply global safety regulations • Demonstrated ability to implement PV strategies and develop PV systems and procedures • Professional level in English, both in oral and written communications • Demonstrate strong leadership and collaboration skills by effectively leading and aligning cross-functional teams • Advanced decision-making and problem-solving skills • Strong communication and leadership skills

🏖️ Benefits

• Professional growth and career opportunities • International team and environment • Bonus based on annual performance • Personal accident and business trip insurance • Additional health insurance • Remote/home-based position • Rewarding referral policy • Workplace establishment allowance • Team building, global meetings, B active events