Manager/Senior Manager of Clinical Safety
Manager/Senior Manager of Clinical Safety
Position Summary:
The Manager/Senior Manager of Clinical Safety will play a key role in supporting the safety assessment, evaluation, and risk management of products in various stages of development as well as involvement in safety surveillance activities.
Key Responsibilities:
- Review ICSRs (including case narratives, causality assessments, and coding) for assigned projects
- Assist with oversite of clinical pharmacovigilance vendor activities including but not limited to assessment, evaluation, tracking and reconciliation of safety information. Oversee monthly reconciliation process performed by PV vendor
- Review eCRF data listings, as assigned, for inconsistencies and provide draft queries to appropriate team members
- Assist with data collection for development of safety content for relevant safety documents
- Review relevant study documents for safety-related information for assigned projects (e.g. Protocols, Safety Management Plan, SAE Reconciliation Plan, CRF, etc.)
- Support aggregate report deliverables, such as writing and review of regulatory safety documents for assigned projects, e.g., Development Safety Update Reports (DSURs), Mexico annual report.
- Interface with outside partners and vendors for clinical pharmacovigilance around patient safety related tasks
- Assist with Adjudication Committee activities including case identification, tracking, collection of appropriate data/records for submission to adjudication database
- Assist with Data Monitoring Committee activities, as needed
- Assist with other PV compliance activities as required
- Other duties as assigned
Qualifications and Skills Required:
- Bachelor’s degree in relevant scientific discipline. Clinical experience (e.g. RN, BSN, or PharmD) is preferred, but not required.
- Drug Safety professional with minimum 5 years of experience within drug safety and PV inclusive of case quality control and regulatory submissions of ICSRs worldwide
- Ability to interpret health and medical records such as adverse event reporting forms, discharge summary, etc
- Experience with safety databases; Argus is a plus but not mandatory
- Experience with EDC for clinical trial data collection
- Experience with clinical case processing, including MedDRA and WHO Drug coding and narrative writing
- Good knowledge of pharmacovigilance reporting rules and timelines
- Good knowledge of ICH E2B(R2) and (R3) specifications and entry guidance
- Experience in managing external teams preferred
- Excellent written and verbal communication skills
- Excellent in detailed-oriented tasks
