Senior Scientist, Risk Management & Safety Surveillance

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Senior Scientist, Risk Management & Safety Surveillance on a permanent basis.

The scientist will be responsible for core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned reports (medium to large volume, standard complexity). He/She will have in- depth product knowledge and will support Safety Management Team (SMT) deliverables as required. Daily activities involve planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, and project management/coordination of strategic safety documents. He/She will partner with team members, stakeholders including Medical Safety Officers (MSOs), and a vendor.

• Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate

• Collaborate with Therapeutic Area Safety Head (TASH), MSO, 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, and coordinate the preparation of core safety deliverables

• Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs) and assessment reports) are met

• Partner with vendor to develop reports/deliverables

• Provide SMT support as needed

• Act as ad hoc member for assigned products as appropriate

• Recognize potential issues and or safety issues and escalate to the attention of the report owner, line manager, or MSO

• Ability to understand nature of adverse drug reactions and complex associations

• Maintains a high level of flexibility and ability to reprioritize ones work and others

• Attention to detail and ability to analyze data in broader context

• Ability to work across multiple functions and therapeutic areas

• Review regulatory assessor comments/requests and accommodate/address as appropriate with guidance

• Participate in cross-functional training of relevant stakeholders

• Attend departmental meetings and trainings

• Participate in department and/or cross-functional initiatives

• Safety Management Teams (SMT) for assigned products - Lead SMT meeting. Lead and drive discussions and formulate decisions along with core members

• Risk management plans - Provide guidance on RMP creation and updates. Reviews and align approvals with oversight leads of the Risk Management plan

• Periodic Benefit Risk Evaluation Report (PBRER)/ Periodic Safety Update Report (PSUR) - Reviews and align approvals with lead oversight. Leads