Senior Manager, Drug Safety & Pharmacovigilance

Travere • San Diego, CA

1d • Remote

About The Position

The Senior Manager, Drug Safety & Pharmacovigilance (DSPV) supports pre- and post-marketing pharmacovigilance activities across DSPV Operations and Safety Science. The role supports day-to-day safety operations, including individual case safety report (ICSR) management, vendor oversight, regulatory reporting compliance, quality and compliance monitoring, and safety data reconciliation. It also supports safety scientist activities, including medical review of ICSRs, clinical safety data review, signal detection and assessment, preparation and review of aggregate safety reports, review of safety information in clinical and regulatory documents, and contributions to risk management and product labeling activities.

The position works with internal teams, service providers, business partners, and licensing partners to maintain compliant and inspection-ready pharmacovigilance processes. It contributes to safety governance, regulatory responses, REMS activities where applicable, and cross-functional safety review meetings. The position is listed as remote in San Diego, but the posting states that all positions require the ability to perform face-to-face work with colleagues and/or onsite in San Diego and that no role is expected to be 100% remote. Travel of 10% domestically and internationally is required, including occasional nights and weekend travel.

Requirements

• Bachelor's degree in life sciences or a related field required; an equivalent combination of education and applicable job experience may be considered.
• At least 6 years of Drug Safety/Pharmacovigilance experience in the pharmaceutical, biotechnology, or CRO industry, including experience in both clinical development and post-marketing environments.
• Strong experience with ICSR processing and/or medical review, including assessment of seriousness, expectedness, causality, coding, case narratives, and query management, as well as regulatory reporting compliance.
• Experience with reconciliation activities, case quality review, and vendor oversight.
• Experience with safety surveillance and signal detection activities.
• Experience contributing to aggregate safety reports such as DSURs, PADERs, PSURs/PBRERs, and other periodic or ad hoc safety analyses.
• Experience reviewing safety information in clinical study documents, including protocols, Investigator's Brochures, informed consent forms, CSRs, and safety data outputs.
• Experience with pharmacovigilance or safety database systems such as ARGUS, ARISg, or equivalent systems.
• Experience with MedDRA and WHO Drug coding conventions.
• Working knowledge of FDA regulations, ICH guidelines, GCP requirements, EU pharmacovigilance requirements, and other applicable global requirements for clinical and post-marketing safety.
• Strong analytical and critical-thinking skills, including the ability to interpret individual and aggregate safety data and identify potential safety issues.
• Strong written and verbal communication skills and ability to communicate safety information clearly to cross-functional stakeholders.
• Ability to work independently and collaborate effectively in cross-functional and matrixed team environments.
• Strong organizational, prioritization, and time-management skills, including the ability to manage multiple projects and competing priorities.
• Detail-oriented, with commitment to data quality, regulatory compliance, and timely execution.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Ability to travel 10% domestically and internationally, including occasional nights and weekend travel.
• Ability to perform face-to-face work with colleagues and/or onsite in San Diego.

Nice To Haves

• Healthcare professional or relevant health/biomedical science degree, such as RN, BSN, PharmD, PA, or NP, particularly for medical review responsibilities.
• Knowledge of REMS programs and/or REMS program management.
• Experience in nephrology and/or rare diseases.
• Alignment with Travere's core values: Courage, Community Spirit, Patient Focus, and Teamwork; driven, intelligent, and passionate about making a difference for patients with rare diseases.

Responsibilities

• Manage day-to-day pharmacovigilance operations performed internally and by PV service providers, including clinical trial and post-marketing case processing.
• Monitor compliance with global regulatory requirements and expedited safety reporting timelines.
• Perform quality review of ICSRs, safety forms, narratives, and other safety documentation for completeness, accuracy, consistency, and regulatory compliance.
• Monitor PV vendor performance using KPIs, compliance metrics, quality findings, and operational issues, and facilitate resolution or escalation.
• Perform safety data reconciliations, including SAE reconciliation with clinical databases and vendor reconciliations.
• Support PV activities with business and licensing partners to ensure compliance with pharmacovigilance agreements, SDEAs, contracts, and procedures.
• Support development and maintenance of Safety Management Plans, Vendor Oversight Plans, and SAE Reconciliation Plans.
• Lead or coordinate investigations of PV deviations and quality events and drive CAPA development, implementation, and effectiveness monitoring.
• Support PV inspection and audit readiness and maintain inspection-ready pharmacovigilance documentation.
• Participate in regulatory inspections and internal or external audits, including preparing requested documentation and responses to findings.
• Contribute to developing, revising, and implementing PV SOPs, Work Instructions, procedural documents, and training materials.
• Support departmental project management, including safety team meetings, tracking deliverables and timelines, meeting documentation, and archiving PV records.
• Perform medical review of clinical trial and post-marketing ICSRs, including review of coding, seriousness, expectedness, causality, narratives, listedness, and overall case quality.
• Review clinical study safety data and identify findings, trends, inconsistencies, or potential issues requiring further evaluation.
• Review MedDRA coding and other safety-related coding of clinical and post-marketing data, as appropriate.
• Contribute to planning, preparation, authoring, review, and quality control of aggregate and periodic safety reports, including DSURs, PADERs, PSURs/PBRERs, periodic line listings, and ad hoc safety analyses.
• Review and contribute to safety sections of clinical and regulatory documents, including Investigator's Brochures, protocols, informed consent forms, statistical analysis plans, CSRs, and other relevant documents.
• Support safety signal management through review of adverse event and aggregate data, literature, regulatory information, and other safety sources; evaluate, validate, assess, document, and track potential signals.
• Assist in developing and maintaining Risk Management Plans and other risk-management documentation.
• Support preparation and review of responses to health authority inquiries and requests related to product safety.
• Support REMS activities where applicable, including operations, vendor oversight, review of REMS materials, and compliance monitoring.
• Serve as a DSPV subject matter expert in cross-functional safety governance activities and safety review meetings, as assigned.
• Perform additional duties as assigned.

Benefits

• Premium health, financial, work-life, and well-being offerings for eligible employees and dependents.
• Wellness and employee support programs.
• Life insurance.
• Disability benefits.
• Retirement plans with employer match.
• Generous paid time off.
• Cash compensation comprising base pay and short-term incentive.
• Long-term incentive compensation in company stock.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior