Senior Director, Head of Pharmacovigilance

6 days ago

New York, New York, United States Planet Pharma Full time
About the Role

We are seeking a highly experienced and strategic Senior Director, Head of Pharmacovigilance to lead our Pharmacovigilance function at Planet Pharma. This is a critical role that requires a deep understanding of pharmacovigilance regulations, risk management, and regulatory requirements.

Key Responsibilities
  • Leadership and Strategy: Develop and execute the global pharmacovigilance strategy in alignment with company goals and regulatory requirements.
  • Operational Management: Build and lead a high-performing pharmacovigilance team, providing mentorship, guidance, and professional development opportunities.
  • Regulatory Compliance: Ensure compliance with global pharmacovigilance regulations, including FDA, EMA, and other relevant health authorities.
  • Risk Management: Develop and implement robust risk management strategies, including the identification, assessment, and mitigation of risks associated with development assets.
  • Cross-Functional Collaboration: Partner with Clinical Development, Clinical Operations, and Regulatory to ensure alignment on safety monitoring and signal detection activities.
Requirements
  • Advanced degree in life sciences, medicine, pharmacy, or a related field (MD preferred)
  • A minimum of 10 years of experience in pharmacovigilance within the biopharmaceutical industry
  • Extensive experience with global pharmacovigilance regulations, including FDA, EMA, and other international health authorities.
  • Proven track record of building and leading successful pharmacovigilance teams and functions.
  • Strong strategic and analytical thinking with the ability to translate complex data into actionable insights.
  • Excellent leadership and team-building skills, with the ability to inspire and motivate a diverse team.
  • Superior communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders, including regulatory authorities.
Preferred Qualifications
  • Experience in start-up / scale up companies
  • Experience building out functions / departments
  • Experience in people management and leadership
Competencies
  • Ethics: Treats people with respect; Shows respect and sensitivity for cultural differences; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values; Promotes a harassment-free environment.
  • Teamwork: Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
  • Adaptability: Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
  • Analytical: Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
  • Effective Communication: Writes clearly and informatively, with attention to spelling and grammar; adapts writing style to meet various needs; presents numerical data effectively; able to read and interpret written information; speaks clearly and persuasively in different situations; listens actively and responds well to questions; demonstrates strong presentation skills and participates effectively in meetings.
  • Judgement: Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
  • Problem Solving: Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
  • Quality Management: Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
  • Strategic Thinking: Develops strategies to achieve organizational goals; Understands organization's strengths and weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.

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