The Senior Safety Writing Analyst 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 Senior Safety Writing Analyst 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 Senior Safety Writing Analyst will partner with team members, stakeholders including Medical Safety Officers (MSOs) and a vendor.

Your main duties will include, but not be restricted to:

• 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.
• Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs),
  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.
• Training/Meetings/Department initiatives.
• Participate in cross-functional training of relevant stakeholders.
• Attend departmental meetings and trainings.
• Participate in department and/or cross-functional initiatives.

Education/Qualifications:

• 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).

Experience:

• Clinical/Medical writing or PV experience preferred.
• Strong English verbal and written communication skills.
• Clinical/Medical writing or PV experience preferred.
• Strong English verbal and written communication skills.

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