Job Details

Position Summary:
The Senior Manager, Drug Safety & Pharmacovigilance (DSPV) will support pre- and post-marketing pharmacovigilance activities across both DSPV Operations and Safety Science. This position will be responsible for supporting 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. The Senior Manager, DSPV will also support 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 contribution to risk management and product labeling activities.
 
Responsibilities:
PV Operations and Compliance

• Manage the day-to-day pharmacovigilance operations performed internally and by PV service providers, including clinical trial and post-marketing case processing activities.
• Monitor compliance with global regulatory requirements and reporting timelines for expedited safety reports.
• Perform quality review of ICSRs, safety forms, narratives, and other safety documentation to ensure completeness, accuracy, consistency, and regulatory compliance.
• Monitor PV vendor performance, including review of key performance indicators (KPIs), compliance metrics, quality findings, and operational issues, and facilitate timely resolution and escalation as appropriate.
• Perform safety data reconciliations, including SAE reconciliation with clinical databases, vendor reconciliations, and other safety data reconciliation activities.
• Support PV activities involving business partners and licensing partners to ensure compliance with pharmacovigilance agreements, Safety Data Exchange Agreements (SDEAs), contracts, and applicable procedures.
• Support the development and maintenance of safety-related plans, including Safety Management Plans, Vendor Oversight Plans, and SAE Reconciliation Plans.
• Lead or coordinate investigation of PV deviations and quality events and drive the development, implementation, and effectiveness monitoring of corrective and preventive actions (CAPAs).
• Support PV inspection and audit readiness activities and maintain pharmacovigilance documentation in an inspection-ready state.
• Participate in regulatory inspections and internal or external audits involving pharmacovigilance, including preparation of requested documentation and responses to findings.
• Contribute to the development, revision, and implementation of PV SOPs, Work Instructions, procedural documents, and training materials.
• Support departmental project management activities, including safety team meetings, tracking deliverables and timelines, meeting documentation, and appropriate archiving of PV records.

 
Safety Science and Medical Review

• Perform medical review of ICSRs from clinical trials and post-marketing sources, including review of adverse event coding, seriousness, expectedness, causality, narratives, listedness, and overall case quality.
• Contribute to ongoing medical and safety review of clinical study data and identify safety 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 the 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 key clinical and regulatory documents, including Investigator’s Brochures, clinical study protocols, informed consent forms, statistical analysis plans, clinical study reports (CSRs), and other relevant documents.
• Support routine safety signal management activities, including review of adverse event data, aggregate data, literature, regulatory information, and other relevant safety sources; evaluation, validation, assessment, documentation, and tracking of potential safety signals in accordance with company procedures and applicable global regulatory requirements.
• Assist in the development and maintenance of Risk Management Plans and other risk-management documentation.
• Support preparation and review of responses to health authority inquiries and requests for information related to product safety.
• Support REMS activities, where applicable, including operational activities, vendor oversight, review of REMS materials, and compliance monitoring.
• Act as the DSPV subject matter expert in cross-functional safety governance activities and safety review meetings, as assigned.
• Additional duties assigned as needed.

 
Education/Experience Requirements:  

• Bachelor’s degree in life sciences or related field required. Healthcare professional or relevant health/biomedical science degree; RN, BSN, PharmD, PA, NP, or similar healthcare-related qualification preferred, particularly for responsibilities involving medical review of safety cases. Equivalent combination of education and applicable job experience may be considered.
• 6+ years of experience in Drug Safety/Pharmacovigilance within the pharmaceutical, biotechnology, or CRO industry, with experience in both clinical development and post-marketing pharmacovigilance environments.
• Strong experience with ICSR processing and/or medical review, including assessment of seriousness, expectedness, causality, coding, case narratives, and query management; and regulatory reporting compliance.

 
Additional Skills/Experience:

• The ideal candidate will embody company core values: Courage, Community Spirit, Patient Focus and Teamwork.
• Driven, intelligent, passionate about making a difference for patients with rare diseases.
• 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/safety database systems such as ARGUS, ARISg, or equivalent systems.
• Experience in 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.
• Knowledge of REMS programs and/or REMS program management preferred.
• Strong analytical and critical-thinking skills with the ability to interpret individual and aggregate safety data and identify potential safety issues.
• Strong written and verbal communication skills and the ability to communicate safety information clearly to cross-functional stakeholders.
• Ability to work independently while effectively collaborating in cross-functional and matrixed team environments.
• Strong organizational, prioritization, and time-management skills with the ability to manage multiple projects and competing priorities.
• Detail-oriented with a strong commitment to data quality, regulatory compliance, and timely execution.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Experience in nephrology and/or rare diseases is preferred.
• Ability to travel 10% domestically and internationally, including occasional nights and weekend travel.
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

Comp based on experience $132-172K