Associate Director, Patient Safety & Pharmacovigilance Science

Corcept Therapeutics; Redwood City (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics in Redwood City, California seeks a Senior Safety Scientist responsible for monitoring and analyzing safety data for investigational and marketed products, with a focus on signal detection, risk management, and safety governance. The role includes developing safety documentation (RMPs/REMS) and authoring safety reports (ISS, PBRERs).

You will support regulatory submissions, mentor junior staff, and collaborate with cross-functional teams to assess benefit–risk and prepare

Qualifications

• BS/BA in a related field with 4+ years of pharmacovigilance experience.
• Experience with signal detection, safety surveillance, risk management and safety reporting.
• Strong communication skills and ability to collaborate with cross-functional teams.

Responsibilities

• Monitor and analyze safety data for investigational and marketed products.
• Perform signal detection, risk management, and safety governance activities.
• Develop safety documentation such as RMPs and REMS; author ISS and PBRERs.
• Support regulatory submissions and prepare safety content for agencies.
• Mentor junior team members and collaborate cross-functionally on benefit-risk assessments.

Skills

Pharmacovigilance

Signal detection

Safety reporting

Regulatory knowledge

Education

Bachelor's degree in a related field

Tools

Argus

Job description

Role: Senior safety scientist

responsible for monitoring and analyzing safety data of Corcept's investigational and marketed products, primarily in hypercortisolism, oncology, ALS, and liver disease. Responsibilities include performing safety data analyses, signal detection, risk management, developing safety documentation (RMPs, REMS), authoring safety reports (e.g., ISS, PBRERs), supporting regulatory submissions, and collaborating with cross-functional teams on safety governance and benefit-risk assessments. The role involves working closely with safety physicians, preparing safety content for regulatory agencies, and mentoring junior team members.

Requirements:

• BS/BA in a related field with 4+ years of pharmacovigilance experience, including signal detection, safety surveillance, risk management, and safety reporting;
• Experience with pharmacovigilance systems like Argus;
• Knowledge of global PV regulations (ICH, GVP, FDA, EMA);
• Strong communication skills.

Preferred:

• PhD, PharmD, or advanced degree;
• 2+ years of clinical development experience;
• Familiarity with NDA/MAA filing;
• Epidemiology/public health background beneficial.

Location:

The position is headquarters-based in Redwood City, California, with a focus on safety monitoring in a dynamic environment.