Retrophin Inc is seeking a seasoned leader to oversee the overall development of the Pharmacovigilance department. The Vice President, Pharmacovigilance will report directly to the Chief Medical Officer. The successful candidate will be responsible for the strategic global implementation, execution, and management of Pharmacovigilance and risk management activities in conjunction with the Company’s development and commercial activities, industry standards, and compliance with global regulations. This role will lead and provide medical oversight for the pharmacovigilance, drug safety and risk management functions for investigational and marketed products, ensuring proactive and timely risk-benefit assessments of safety data.
- Develop and direct global strategic Pharmacovigilance to align with corporate clinical development and commercial goals.
- Direct the global Pharmacovigilance activities and processes for products in clinical development and marketed products.
- Lead and oversee Pharmacovigilance signal detection and risk management activities for all products in clinical development and implement appropriate risk mitigation strategies to ensure patient safety.
- Oversee and direct all aspects of pharmacovigilance and risk management activities for investigational compounds and marketed products; actively participate in oversight of patient safety in all clinical trials.
- Provide strategic planning and Pharmacovigilance input to support product regulatory submissions (IND, NDA, and product labeling).
- Participate in oversight of patient safety in clinical development clinical trials.
- Provide strategic planning, assessment and ensure the implementation of pharmacovigilance activities to support products in clinical development.
- Lead and serve as Pharmacovigilance expert in responding to and resolving safety questions received from or requested by regulatory authorities.
- Provide medical safety expertise in reviewing critical documents for clinical development products.
- Lead Pharmacovigilance Committee meetings and manage communication of product risk-benefit profile to internal and external stakeholders.
- Actively participate and serve as Pharmacovigilance representative in senior leadership committees.
- Lead internal safety team and oversee safety vendors to ensure timely delivery and high quality of Pharmacovigilance and safety deliverables.
- MD degree with 15 years experience in Life Sciences and/or Pharmaceuticals industry.
- 10 years experience in global pharmacovigilance and drug safety.
- Demonstrated leadership experience managing internal teams and external partners.
- Expertise in global safety regulations – FDA, EU GVP, ICH guidelines, and other applicable global safety regulations and guidance.
- Expertise in clinical safety assessments, signal detection and risk management, including interactions with regulatory authorities
- Experience in Pharmacovigilance inspections.
- Experience and knowledge in IND and NDA submissions.
- Demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
- Excellent communication skills (verbal and written).
- Strategic assessment and evaluation skills with strong decision-making abilities.
- Ability to navigate fast-paced and dynamic work environment with ability to collaborate with various functions.
- Strong leader with teamwork and collaborative perspective.