Associate Director, Pharmacovigilance

About the Role

The Associate Director, Pharmacovigilance reports to our Senior Director, Pharmacovigilance at Tarsus. This person will work with PV team and cross-functional members to lead and implement robust Drug Safety Surveillance, Signal management, and authoring Aggregate safety reports activities. Additionally, support the content of the Reference Safety Information (RSI), Core Company Safety Information (CCSI) and safety sections of the post marketed labels and clinical safety sections in pipeline projects. Lead and assist with Health authority/ agency safety query response preparation, and other safety documents. Lead and support Quality Management Systems maintenance and updates to help build and maintain a robust PV compliance system at Tarsus.

Let’s talk about some of the key responsibilities of the role:

• Lead signal detection and management processes, including routine safety data reviews, evaluation of new safety signals as a subject matter expert (SME)
• Contribute to pharmacovigilance data analytics projects, streamline signal management processes, and ensure compliance with global PV regulations and ICH/GCP guidelines.
• Conduct medical review of Individual case safety reports (ICSRs) from clinical trials and post-marketing cases, ensuring accurate medical evaluation, MedDRA coding, and company causality assessments.
• Assist preparation and review aggregate safety reports, clinical trial documents, regulatory filings, and responses to safety queries from clinical sites.
• Lead safety strategy for benefit-risk assessments, Safety Governance activities to maintain Vendors / Business partners KPIs, and contributing to Safety Data Monitoring Committee activities.
• Case monitoring review activities, update/review on RSI section of IBs and Safety sections of Clinical Protocols, and Clinical Study Report (CSRs) and Periodic clinical safety data review (ongoing basis) for signalling review and management for pipeline projects.
• PV Collaboration on SMT meetings as per PV/SDEA agreements for Business partners, PV vendors and CROs including RMP updates, safety-related labelling updates.
• Support and Lead development of safety management plans (SMPs), SDEA/PV agreements, and safety risk management sections of other documents (e.g., integrated safety summary documents, NDA safety sections, RA/HA query response etc).
• Support and Assist as a SME to ensure inspection readiness by aligning PV practices with regulatory expectations, overseeing safety vendor activities, and driving quality management initiatives.
• Support Safety Management activities with Business Partners and/or other PV vendors collaborations on Xdemvy and/or clinical pipeline projects.
• Lead cross-functional projects and provide SME supports on safety updates, challenges, solutions, and project status.
• Support preparation and execution of regulatory/HA inspections activities.
• Stay updated on regulatory standards, participate in training sessions and conferences, and contribute to continuous improvement of PV systems and processes.
• Maintain up to date knowledge of pharmacovigilance and drug safety related regulations, the regulatory environment, and company SOPs.
• Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and regulatory compliance of the pharmacovigilance and drug safety system and quality assurance activities.

Factors for Success:

• Bachelor’s degree in science or healthcare field (MD/MBBS/BDS, BSN, Nurse practitioner, etc)
• 10+ years of significant DSPV experience in clinical and post-marketing settings with biotech or pharmaceutical industry experience; including a minimum of 5 years in Clinical Safety/ Pharmacovigilance activities including signal management activities, authoring Aggregate safety reports, Health authority/ agency safety query response preparation
• Experience with safety labeling activities, Reference Safety Information, Core Company Safety Information (CCSI) and safety sections of the post marketed labels.
• Working experience and strong understanding of global pharmacovigilance regulations, FDA/GVP/ICH guidance, and industry best practices including Good Clinical Practices (GCP)
• Working experience on regulatory agencies inspections and/or internal or third-party audits
• Proficient in ICSR and SUSARs case processing processes, procedures, conventions
• Excellent communication skills, both written and verbal, with the ability to interact effectively with cross-functional teams and external vendors.
• Detail-oriented with strong analytical thinking and problem-solving capabilities.
• Advance experience using excel file for data review and analysis.

A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. [Remote work is also an option.]
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to Senior Director, Pharmacovigilance
• Some travel may be required – up to 20%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $161,200 - $225,800 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://alliantbenefits.cld.bz/25tarsusbenesnap.

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