SRG, the leader in the Life Sciences human capital industry, is looking for a Drug Safety Senior Specialist our client's pharmaceutical manufacturing team in Waltham, Mass.

Please indicate years of experience with drug safety, clinical safety, and Oncology at the top of your resume.

*Long term contract with extension

*Hybrid onsite 3 days a week

MUST HAVES:

• Clinical degree (e.g., RPh/PharmD, BSN, RN)
• 3-5 years drug safety or clinical safety experience
• 2 years clinical experience in a medical setting, demonstrate general medical and pharmacology knowledge
• Experience processing Oncology cases preferred
• Have demonstrated knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidance related to pharmacovigilance and Good Clinical Practices
• Ability to make clinical decisions and formulate appropriate queries based on sound medical knowledge
• Competence with commercial safety application databases such as Clintrace, ArisG or Argus
• Knowledge of clinical trial database (e.g., Trailmaster) is a plus

JOB RESPONSIBILITIES:

• Responsible for the processing adverse event reports that include but not limited to the receipt, evaluation, reviewing and reporting of adverse event information for marketed and investigational products in accordance with ICH guidelines and applicable regulatory requirements including the FDA, Alkermes SOPs, and applicable licensing or partnership agreements.
• Track cases from receipt to closure and work with clinical, regulatory, and contract research organizations (CROs) to ensure that all post-market and clinical safety pharmacovigilance activities are performed across ongoing projects independently.
• Perform verification of safety data and will utilize clinical judgement in coding of verbatim adverse events, medical history, and medications.
• Ability to synthesize complex clinical information into accurate and complete reports.
• Actively obtains follow-up through event resolution.
• Performs SAE reconciliation, ensuring completeness and closure of cases in a timely fashion.
• Acts as a safety representative and facilitator between external reporting sources.
• Contributes to the development and writing of industry standard operating procedures and processes for pharmacovigilance activities including writing of the Safety Management Plan for assigned studies to ensure the uniform and timely processing of adverse event reports.

* Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.