Sr Pharmacovigilance Scientist II - 100% remote *EU only*

My client, one of world's most established pharmaceutical companies is looking for a Senior Pharmacovigilance Scientist II who 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). The Sr. Scientist 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. The Sr. Scientist will partner with team members, stakeholders including Medical Safety Officers (MSOs), and a vendor.

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/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;
• Partner with vendor to develop reports/deliverables;
• Provide SMT support as needed;
• Act as ad hoc member for assigned products as appropriate;
• Training/Meetings/Department initiatives;
• Participate in cross-functional training of relevant stakeholders;
• Attend departmental meetings and trainings;
• Recognize potential issues and or safety issues and escalate to the attention of the report owner, line manager, or MSO;
• Review regulatory assessor comments/requests and accommodate/address as appropriate with guidance

What we are looking for:

• Bachelor's Degree in Health or Biomedical Science (6-8 years industry experience or equivalent)
• Advanced Degree Preferred in Health or Biomedical Science (4-6 years industry experience or equivalent)
• Clinical/Medical writing or PV experience preferred
• Strong English verbal and written communication skills

If this job sounds interesting to you, please apply here or send your CV to me, Sofie Thijs, via the web page of NonStop consulting. You can find me on Linked In as well. If you are not available but you know someone that would be interested, please forward this to them and help out the people in your network!