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Biomapas

A complete spectrum of Clinical Research, Regulatory Affairs, Pharmacovigilance and Medical Information solutions.

Associate Director – International PV

DirectorDirectorFull TimeRemoteSeniorTeam 201-500H1B No SponsorCompany SiteLinkedIn

Location

Croatia

Posted

2 days ago

Salary

0

Seniority

Senior

Postgraduate Degree6 yrs expEnglish

Job Description

Associate Director – International PV

Biomapas

• 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.

Job 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

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