Job Description

Associate Director - Contract - Boston, MA - REMOTE

Are you ready to make a groundbreaking impact in the world of biotechnology? Join a growing company that's shaping the future of healthcare and science.

Proclinical is seeking an Associate Director, Pharmacovigilance Scientist for a remote role based in Boston, MA.

Primary Responsibilities:

The successful candidate will focus on supporting risk management and safety data analysis within the gene therapy and biotechnology sector. You will play a crucial role in ensuring drug safety and compliance with regulatory standards.

Skills & Requirements:

• Degree in Medicine, Biological Sciences, Nursing, or Pharmacy.
• Experience in risk management and safety reporting in Drug Safety / Pharmacovigilance.
• Familiarity with Pharmacovigilance and Risk Management regulations and guidelines.
• Working knowledge of MedDRA, MedDRA SMQs, and Safety Databases.
• Experience with safety reviews of clinical and post-marketing safety data/documents.
• Strong communication skills and ability to interpret data for global teams.
• Ability to contribute to process improvement initiatives.
• Effective representation in cross-functional meetings.

The Associate Director's responsibilities will be:

• Support risk management activities by preparing and analyzing safety data for integration into various safety documents.
• Conduct routine signal detection and analysis, maintaining the signal management tracker.
• Prepare presentations and contribute to discussions in cross-functional safety governance forums.
• Investigate potential drug-related adverse events and provide data analysis.
• Facilitate timely presentation of safety issues to governance bodies.
• Participate in medical safety oversight of clinical trials and contribute to protocol development and safety data evaluation.
• Review individual case safety reports and periodic safety reports.
• Contribute to safety evaluation and risk management sections of periodic reports.
• Develop interdepartmental processes and procedures.

Compensation:

• $75.00 - $100.00 Per Hour

If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at [email protected]

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.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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