Associate Director – Pharmacovigilance – Safety Scientist

Associate Director – Pharmacovigilance – Safety Scientist

Requirements

• Advanced healthcare professional degree required (PharmD, PA or NP)
• A minimum 5+ years experience in Drug Safety/Pharmacovigilance for a biotech/pharmaceutical company in clinical and post marketing environments
• Equivalent combination of education and applicable job experience may be considered

Responsibilities

• Performs medical review of ICSRs from clinical trials and post market reports (coding, expectedness, causality, seriousness and narratives) to ensure quality and accuracy of reports
• Participates in Medical Data Review of clinical study data
• Performs coding review of study safety data
• Leads and/or contributes to the planning, preparation, writing, review and QC of aggregate safety reports (e.g. PADER, PSUR/PBRER, DSUR)
• Reviews and contributes to safety sections of key study documents such as Investigator Brochures, protocols, statistical analysis plans, informed consent forms, and CSRs
• Reviews tables, figures, and listings for safety data from clinical studies
• Manages signal detection activities, including adverse event data and literature review in accordance to the SOP related to safety signal management, and oversight of vendor delegated to conduct signal detection, if applicable
• Assists and contributes to the development of risk management plans and product labels (e.g. USPI, EU SmPC)
• Supports the REMS program activities such as operational oversight for all REMS related activities, REMS vendor oversight, and development of REMS materials
• Performs medical review of product complaints and potential product quality problems and escalate if there is a need for safety quality investigations
• Assists in preparation of response to regulatory inquiries related to safety
• Prepares training materials for internal and external safety presentations (ie Investigators Meetings, SIVs)
• Supports regulatory inspections and audits, and inspection readiness activities
• Assists in authoring and/or review of PV SOPs and/or Work Instructions
• Other responsibilities as assigned by his/her supervisor

Preferred Qualifications

• Knowledge and some experience in REMS Program Management
• Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA regulations and guidelines, and other international regulatory requirements
• Experience with MedDRA and WHO Drug dictionary coding
• Experience with software-based drug safety systems (e.g. ARGUS, ARISg, etc.)
• Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment
• Detail-oriented, with good organizational, prioritization, and time management proficiencies
• Must be able to work on multiple projects simultaneously
• Ability to prioritize work without much support
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
• Proficient in standard computer software (Word, Excel and Power Point)
• Some travel on-site in San Diego, as required