The Pharmacovigilance Medical Writer will be responsible for authoring and revising key drug safety- focused documents and reports for submission to the FDA and other regulatory health agencies. They will work closely with medical and safety colleagues to prepare accurate and concise analyses of safety data to support development of new treatments as well as support post-marketing safety activities for approved agents.
Lead the authoring and editing of periodic aggregate safety reports, including but not limited to PBRER/PSUR, PADER, DSUR, and IND annual reports in collaboration with Safety Evaluation and Risk Management (SERM), safety scientists, and medical colleagues
Author, write, and edit RMPs and REMS in collaboration with Safety Evaluation and Risk Management (SERM), safety scientists, and medical colleagues
In collaboration with study medical writers review safety sections for clinical protocols, IBs, subject consent forms, and other clinical/regulatory documents
Understand relationships and dependencies between documents and analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and other annual reports and/or deliverables
Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues
Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission
Provide project teams with expertise and strategic guidance on analysis and presentation of safety data and on benefit-risk assessment in documents
Author safety summaries to support communication of relevant safety information both internally and externally
Produce high quality, accurate, and fit- for-purpose evaluation documents with clear conclusions, in response to internal or regulatory authority request for safety reasons
Review the worldwide medical/scientific literature to identify signals and applicable information for inclusion in aggregate safety reports in collaboration with SERM colleagues
Draft regulatory response documents such as PRAC assessment reports
Draft other medical writing deliverables as needed
Minimum of 3-5 years scientific experience in the biopharmaceutical industry; post-doctoral research may be considered in lieu of industry experience
Excellent written and verbal communication skills with the ability to interpret and present statistical and clinical data to varied audiences
Knowledge of FDA and EMA regulations, ICH guidelines, Good Clinical Practices and the drug development process
Knowledge of drug safety/pharmacovigilance practices and tools
Must have the ability to coordinate and prioritize multiple projects in a fast-paced environment with limited to little supervision
Background in oncology drug development is a plus
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.