Job Description
Job Description:
The Senior Director, Head of Pharmacovigilance will be responsible for establishing and leading the Pharmacovigilance (PV) function within the company. Reporting directly to the Chief Development Officer, this role will be pivotal in developing the strategy, systems, and processes necessary to ensure the safety of our assets throughout their lifecycle. The successful candidate will be a strategic thinker with deep expertise in pharmacovigilance, risk management, and regulatory requirements
Essential Duties and Responsibilities Leadership and Strategy :
- Develop and execute the global pharmacovigilance strategy in alignment with company goals and regulatory requirements.
- Lead the creation, implementation, and continuous improvement of the pharmacovigilance function, including systems, processes, and governance.
- Collaborate closely with cross-functional teams, including Clinical Development, Regulatory Affairs, Quality Assurance, and Medical Affairs, to ensure integrated safety oversight.
- Foster a culture of continuous improvement within the pharmacovigilance function, staying abreast of industry trends and best practices.
Operational Management :
- Build and lead a high-performing pharmacovigilance team, providing mentorship, guidance, and professional development opportunities.
- Oversee the identification, evaluation, and management of safety signals, ensuring timely and accurate reporting to regulatory authorities.
- Establish and maintain pharmacovigilance agreements with partners, CROs, and other third parties.
Regulatory Compliance :
- Ensure compliance with global pharmacovigilance regulations, including FDA, EMA, and other relevant health authorities.
- Lead the preparation and submission of safety-related regulatory documents, including Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).
Risk Management :
- Develop and implement robust risk management strategies, including the identification, assessment, and mitigation of risks associated with development assets.
- Monitor and analyze safety data to identify potential safety concerns and take appropriate action.
Cross-Functional Collaboration :
- Partner with Clinical Development, Clinical Operations, and Regulatory to ensure alignment on safety monitoring and signal detection activities.
- Collaborate with Quality Assurance to ensure that pharmacovigilance activities are integrated into the company’s quality management system.
- Performs other related duties as assigned by management.
Required Qualifications: - 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.
- Proficiency in pharmacovigilance systems and tools (i.e. Veeva, ArisG, Argus) as well as safety database management.
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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