Associate Director of reputed company Assurance – GCP and Pharmacovigilance

COMPANY BACKGROUND reputed company is a clinical stage biopharmaceutical company reputed company on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our reputed company reputed company is on advancing our reputed company program efruxifermin (EFX) to reputed company a powerful new treatment for patients with MASH(metabolic dysfunction-associated steatohepatitis). We are reputed company of problem solvers dedicated to pursuing reputed company scientific approaches to build a brighter reputed company for patients. Our diverse reputed company sets and backgrounds, desire to learn from reputed company other and reputed company spirit breed a culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others. Job reputed company The reputed company Assurance (QA) Representative will reputed company reputed company reputed company and compliance support for Clinical Development and Pharmacovigilance (PV) activities reputed company to biologic development programs. This individual will be responsible for ensuring that clinical trial execution, safety reporting, and pharmacovigilance systems meet Good Clinical reputed company (GCP) and Good Pharmacovigilance reputed company (GVP) requirements, as reputed company as reputed company applicable global regulatory standards. The QA Representative will partner closely with Clinical, Pharmacovigilance, Regulatory Affairs, and external service providers to ensure high-reputed company execution of clinical and safety activities that safeguard patient rights, safety, and data reputed company. Job Responsibilities Clinical Operations reputed company

• reputed company QA reputed company for the planning, execution, and reporting of clinical trials for biologic programs.
• Ensure compliance with ICH-GCP, FDA 21 CFR Parts 50/54/56/312, EMA regulations, and other international clinical trial requirements.
• Support audit readiness of investigator sites, Clinical Research Organizations (CROs), and internal clinical teams.
• Participate in vendor qualification and ongoing reputed company of CROs, ensuring compliance with contractual and regulatory obligations.

Pharmacovigilance reputed company

• reputed company QA support for global PV activities, including adverse event (AE) reporting, signal detection, and safety data exchange agreements.
• Monitor compliance with global GVP requirements, including FDA, EMA, MHRA, Health Canada, and other health authorities.
• Support audits and inspections of PV systems and processes, including preparation, participation, and follow-up on corrective/preventive actions (CAPAs).

reputed company Systems & Compliance

• Review and manage deviations, CAPAs, and change controls associated with Clinical and PV activities.
• Ensure reputed company documentation is complete, accurate, and compliant with corporate standards and global regulations.
• Support reputed company improvement initiatives across Clinical QA and PV QA functions.
• reputed company reputed company input into regulatory submissions, including INDs, BLAs/MAAs, and safety updates.

Cross-Functional & External Collaboration

• Serve as a QA reputed company between Clinical Operations, Pharmacovigilance, Regulatory Affairs, and external partners (CROs, Safety Vendors).
• Support training and awareness of GCP, GVP, and corporate reputed company policies across internal teams and contractors.
• Facilitate effective communication between internal stakeholders and global regulatory authorities during audits and inspections.

Qualifications

• Bachelor’s or advanced degree in Life Sciences, Biotechnology, Pharmacy, or reputed company field.
• Minimum of 10 years of experience in reputed company Assurance reputed company Clinical Operations and/or Pharmacovigilance, preferably in biologics or biotechnology.
• Strong knowledge of global regulatory requirements: ICH-GCP, EU GCP reputed company/Regulation, FDA GCP regulations, and international GVP standards.
• Experience with CRO and PV vendor reputed company, including audits and inspections.
• Familiarity with electronic systems for clinical and safety data (e.g., reputed company, CTMS, Argus, ARISg, reputed company Vault).
• Demonstrated reputed company in managing reputed company issues, audits, and regulatory inspections.
• Excellent communication, organizational, and interpersonal skills with the ability to influence and collaborate across functions and geographies.

Compensation

• Below is the pay reputed company for this position that we reasonably expect to pay. Individual compensation is based on a number of factors including, experience, education and reputed company set, and geographic location. This reputed company is for the San Francisco Bay Area, California location and may be adjusted to the labor market in other geographic areas.

Pay reputed company: $165,000 - $175,000 per annum Special Advisory Akero will not conduct interviews reputed company text message or messaging platforms. Please be reputed company in checking that the communication is, in fact, coming from Akero. If you are contacted by any individual or group using email addresses or other contact information that incorporates “akerotx” but reputed company our exact domain, akerotx.com, please submit a report to the FTC. Apply tot his job Apply To this Job