Senior Manager, Pharmacovigilance Scientist - Contract - Remote, US
Looking to escape your long commute to work? Unlock your new remote working position with this exciting role in pharmocovigilance!
À±½·ÊÓƵ is seeking a dedicated Senior Manager, Pharmacovigilance Scientist for a fully remote working position.
Primary Responsibilities:
In this role, you will contribute to safety strategies for clinical and post-marketing phases, focusing on safety data review, analysis, and benefit-risk assessments. This position requires a proactive approach to signal detection, safety evaluation, and regulatory documentation.
Skills & Requirements:
- Knowledge of FDA, EU, and ICH guidelines and regulations governing pharmacovigilance activities.
- Experience working with safety system databases for medical case reviews and queries.
- Strong organizational skills with the ability to prioritize tasks and meet deadlines.
- Excellent verbal and written communication skills for presenting safety findings.
- Relevant experience in safety or clinical roles within the pharmaceutical or biotech industry.
- Advanced degree (Master's, PhD, or PharmD) with expertise in risk management or related fields.
- Clinical or industry experience in the therapeutic area of interest is advantageous.
The Senior Manager's responsibilities will be:
- Conduct signal detection activities in alignment with the approved safety surveillance plan.
- Perform signal evaluations and author safety evaluation reports.
- Prepare and review safety documents, including DSURs, PSURs, RMPs, and responses to health authority queries.
- Present findings at Signal Management Team (SMT) meetings and participate in clinical study team discussions.
- Contribute to risk management activities for assigned compounds.
- Represent the safety team on cross-functional committees and external teams, as needed.
- Actively engage in process improvement initiatives, including the development and maintenance of SOPs and related documents.
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Bo Forsen at b.forsen@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
À±½·ÊÓƵ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. À±½·ÊÓƵ is acting as an Employment Agency in relation to this vacancy.
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