Location: Emeryville, CA
Department: Drug Safety & Pharmacovigilance
As a member of Drug Safety & Pharmacovigilance, the Safety Scientist supports the medical component of Drug Safety activities and supports the Drug Safety Physicians in performing safety surveillance activities with a special focus on the identification, evaluation and management of safety risks for Zogenix marketed and investigational products. The Safety Scientist is responsible for a particular aspect(s) or segments of the overall program or a group of products.
- Perform or contribute to signal detection activities and assist Drug Safety Physician in signal identification, evaluation, interpretation of safety signals and creation of safety summaries for internal use, and safety review boards
- Collaborate with other applicable Zogenix functional area specialists including but not limited to Biometrics, Clinical Sciences, Medical Affairs, Product Quality, Regulatory Affairs in collection and integration of safety information for the evaluation and management of safety signals for marketed and investigational products
- Manage the production and/or contribute to the development and maintenance of Risk Management Plans (RMPs) and Risk Evaluation & Mitigation Strategy (REMS) as needed
- Manage the production and/or contribute to the preparation of pre- and post- marketing aggregate safety reports including Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND annual reports, and 6 monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) reports
- Contribute to health authority and other safety related query responses
- Perform review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for Zogenix marketed products
- Support medical review of individual case study reports
- Participate in inspection/audit readiness activities as identified, including provision of requested data and provide support for internal and external PV audits
- Participate in the preparation and maintenance of Reference Safety Information (RSI) and associated product labeling (e.g., Company Core Safety Information (CCSI), Investigator Brochure (IB), national labels, etc.)
- Contribute to the preparation and review of safety section(s) of study protocols, informed consent/assent forms, clinical study reports/synopses, New Drug Application (NDA)/Common Technical Document (CTD) submissions and other documents as needed
- Participate in Safety Management Team (SMT) meetings
- Support study teams’ safety activities related to study initiation, reconciliation, (clinical and registry) for assigned investigational and marketed products.
- Liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities as needed.
- Assist in developing and maintaining standard global procedures and guidelines for Drug Safety operations and participate in designated activities to support revision/creation of pharmacovigilance procedural documents
- Support Drug Safety and Pharmacovigilance initiatives including implementation of safety database, user requirement and enhancements, and validation testing.
- Other duties as assigned.
EDUCATION & EXPERIENCE REQUIREMENTS:
- Registered Nurse or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD)
- Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification)
- 2+ years of experience in pharmaceutical safety-related role
- Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas. Case processing experience is desired
- Working knowledge of relevant FDA, EMA, and ICH guidelines, initiatives and regulations governing drug safety ICSR medical review and processing
Required skills, abilities and competencies include:
- Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.)
- Understanding of medical terminology and ability to summarize medical information
- Ability to follow guidelines and procedural documents (experience of working with Standard Operating Procedures (SOPs) etc. preferred)
- Oriented to quality, attention to detail and accuracy
- Manages own work: ability to prioritize, plan and organize work assignments, and able to work under strict timelines
- Knowledge of safety database systems (e.g. ARGUS, LSS) and general knowledge of MedDRA coding and drug dictionaries