Clinchoice Senior Scientist, Risk Management & Safety Surveillance at ClinChoice manages safety deliverables and aggregate safety analysis for assigned products. Collaborates with cross-functional teams to ensure compliance and safety strategy.
Responsibilities
Position Summary
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.
Primary Responsibilities:
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
Qualification
Education/ExperienceThe Application ProcessOnce you have submitted your CVWho will you be working for?About ClinChoiceOur Company Ethos
Required
Education/Experience:
Bachelor’s degree in Health or Biomedical Science and six to eight years of industry experience or equivalent, or Advanced degree (preferred) in Health or Biomedical Science and four to six years of industry experience or equivalent)
Physician (MD or equivalent) generally requires 2-5 years of pharmacovigilance experience or other relevant experience (e.g., Clinical research, Medical Affairs). Demonstrated skills in clinical medicine with at least 3 years of clinical practice experience is preferred.
Clinical/medical writing or pharmacovigilance experience preferred
Strong English verbal and written communication skills.
Demonstrated knowledge of principles of drug development, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development as well as global safety regulations, is highly preferred.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.