Job Description
Publicly Traded + Equity + Annual Bonus This Jobot Job is hosted by: Katie Griffith
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Salary: $260,000 - $300,000 per year
A bit about us: We are a publicly traded biotechnology company developing biologics to treat chronic dermatological diseases.
Why join us? Competitive Salary
Annual Bonus
Equity
ESPP
401k Program
Medical/Vision/Dental
Remote or Hybrid Schedule
Job Details We are seeking a Medical Director to play a key role in the oversight of pharmacovigilance and drug safety activities in our clinical studies.
This position offers an exciting opportunity to directly impact bringing new medicines to patients in need.
Responsibilities:
- Lead the Pharmacovigilance and Safety team to ensure compliance with global safety standards and regulations.
- Oversee the risk management activities, including risk assessment, risk minimization, and risk communication strategies.
- Ensure accurate and timely processing and review of ICSRs and other safety-related data.
- Provide medical and scientific expertise in the design and interpretation of clinical studies.
- Develop and implement safety surveillance strategies for marketed products and products in development.
- Collaborate with cross-functional teams to address safety-related issues and concerns.
- Lead the preparation and review of safety sections of regulatory documents such as PSURs, DSURs, and RMPs.
- Provide training and guidance to staff on pharmacovigilance and safety-related matters.
- Participate in health authority inspections and audits.
- Stay abreast of the latest developments in the field of pharmacovigilance and safety, ensuring the company's practices are up-to-date and compliant.
Qualifications:
- Medical degree from an accredited institution.
- 5+ years of safety experience in the pharmaceutical industry
- In-depth knowledge of global pharmacovigilance regulations and guidelines.
- Proven experience in risk management, ICSRs, and clinical studies.
- Excellent leadership and team management skills.
- Strong analytical and problem-solving abilities.
- Excellent communication and presentation skills, with the ability to effectively convey complex safety information.
- Proficiency in using safety databases and other relevant software.
- Ability to work in a fast-paced environment and manage multiple priorities.
- Commitment to maintaining the highest ethical standards.
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
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