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Director, Patient Safety and Pharmacovigilance
@Akero Therapeutics
[Hiring] Director, Patient Safety and Pharmacovigilance @Akero Therapeutics
Mar 18, 2025 - Akero Therapeutics is hiring a remote Director, Patient Safety and Pharmacovigilance. 💸 Salary: $250,000 - $300,000 per annum. 📍Location: USA.
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.
Role Description
We are seeking an experienced pharmacovigilance physician to support the development of a promising drug candidate in Phase 3 clinical trials.
- Reporting to the VP, Clinical Development, the successful candidate will play a crucial role in ensuring patient safety and regulatory compliance throughout the drug development process for a key asset.
- Key responsibilities include, but are not limited to:
- Oversight of external pharmacovigilance vendor
- Expert medical review of accumulating serious adverse events in ongoing studies
- Oversight of safety-related regulatory documents (including safety components of BLA submission)
- Medical leadership of internal safety review committee
- Contributing to the development of internal safety infrastructure
Key Responsibilities
- Review and assessment of emerging safety profile, focusing on serious adverse events (SAEs) and potential safety signals from ongoing Phase 3 studies
- Performing signal detection, monitoring and evaluation of all safety signals
- Provide medical oversight for safety surveillance activities and risk management for the Phase 3 drug development program towards BLA submission
- Day-to-day management of external pharmacovigilance vendor relationships including oversight of safety database maintenance and case processing
- Oversee the development and maintenance of safety-related documents including Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), safety sections of the Investigator Brochures, and Risk Management Plans (RMPs)
- Collaborate with individual study medical monitors to evaluate accumulating safety data
- Lead safety review committees and provide medical expertise in safety-related decisions
- Interface with regulatory authorities regarding safety matters and respond to safety-related queries
- Lead preparation of safety components for BLA submission, including:
- Safety sections of Clinical Study Reports
- Response to regulatory safety queries
- Ensure compliance with global safety regulations and reporting requirements
- Contribute to the development of company-wide safety strategies and processes
Qualifications
- MD (Board certified or equivalent)
- Experience in hepatology, MASH or internal medicine preferred
- 3+ years of experience in pharmacovigilance, patient safety or related field in the biopharmaceutical industry
- Experience in preparing or contributing to the preparation of clinical safety assessments and regulatory reports/submissions involving safety information in Phase 3 clinical studies
- Thorough understanding of global pharmacovigilance regulations and guidelines (ICH, FDA, EMA)
- Strong knowledge of drug safety databases and safety reporting requirements
- Experience with signal detection and risk management methodologies
- Prior experience with preparation of documentation of NDA/BLA/MAA submissions an advantage
- Ability to forge cross-functional working relationships with internal teams and external project partners
Technical Requirements and Skills
- Excellent written and verbal communication skills
- Excellent understanding of medical terminology and ability to evaluate complex medical information
- Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
- Able to work both independently and in a team environment, including with external vendors
- Detail-oriented, with good organizational, prioritization, and time management proficiencies, and able to work on multiple projects simultaneously
Compensation
Below is the pay range for this position that we reasonably expect to pay. Individual compensation is based on a number of factors including experience, education and skill set, and geographic location. This range is for the San Francisco Bay Area, California location and may be adjusted to the labor market in other geographic areas.
Pay range: $250,000 - $300,000 per annum
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| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
Back to Remote jobs >
All others
All others
|
Salary
💸
$250,000 - $300,000 per annum
|
Remote
Location
USA
|
|
Job Type
unspecified
|
Posted
Mar 18, 2025
|
️
| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
