C
Senior Scientist, Risk Management & Safety Surveillance
ClinChoice
Contract type
Ongoing
Work mode
On-site · On-site (see listing for address)
Experience
Senior · Not stated
Level inferred from job title
Job description
Key details
- Ensure timely, quality reports and safety analyses related to core deliverables with appropriate oversight
- Collaborate with Therapeutic Area Safety Head (TASH), Medical Safety Officers (MSOs), Safety Surveillance Physician (SSP), and other stakeholders on strategy development
- Initiate, conduct, and oversee searches of internal and external databases
- Perform and/or lead aggregate safety analysis and case-level review
- Author, contribute to, and coordinate preparation of core safety deliverables
- Ensure commitments such as Pharmacovigilance Agreements (PVAs) and assessment reports are met
- Partner with vendor to develop reports and deliverables
- Provide Safety Management Team (SMT) support as needed and act as ad hoc member for assigned products
- Recognize potential issues or safety issues and escalate to report owner, line manager, or MSO
- Review regulatory assessor comments and requests and accommodate or address them with guidance
- Participate in cross-functional training of relevant stakeholders and attend departmental meetings and trainings
- Participate in department and/or cross-functional initiatives
- Lead SMT meetings for assigned products and drive discussions and decisions with core members
- Provide guidance on Risk Management Plan (RMP) creation and updates and align approvals with oversight leads
- Review and align approvals for Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR) and lead PBRER process strategy
- Work with MSO and scientists to organize data, review cases and literature, and write Marketing Authorization Holder (MAH) comments for health authority queries
- Participate in Affiliate Core Data Sheets (CCDS) and US/EU prescribing information updates as part of the label working group
- Work with scientists to review preliminary data for signal validation and lead the signal evaluation process
- Evaluate clinical data for adverse drug reactions (ADRs) and assist with safety sections of Investigator's Brochure (IB) updates
- Company mission
- Information not specified
Benefits
- Information not specified
Requirements & details
- In-depth product knowledge and ability to understand the nature of adverse drug reactions and complex associations
- Attention to detail and ability to analyze data in a broader context
- Ability to work across multiple functions and therapeutic areas
- High level of flexibility and ability to reprioritize own work and others' work
- Experience with planning, conducting meetings, database searching, aggregate safety analysis, case-level review, writing, and project management/coordination of strategic safety documents
- Permanent, in-house position
- Information not specified
- Clinical Research