Associate Director, Pharmacovigilance Scientist

Proclinical Staffing; Boston (MA); Remote; USD 125,000 - 150,000; Full time

Job summary

An innovative firm is seeking an Associate Director, Pharmacovigilance Scientist to join their remote team. This role is pivotal in ensuring drug safety and compliance within the biotechnology sector. You will support risk management and safety data analysis, contributing to critical discussions in cross-functional teams. With a focus on process improvement and effective communication, you will engage in vital activities such as signal detection and safety reviews, making a significant impact on healthcare and safety standards. If you are passionate about biotechnology and ready to take on a leadership role, this opportunity is for you.

Qualifications

• Degree in Medicine, Biological Sciences, Nursing, or Pharmacy required.
• Experience in risk management and safety reporting in Drug Safety.

Responsibilities

• Support risk management activities by analyzing safety data.
• Conduct routine signal detection and maintain the signal management tracker.

Skills

Risk Management

Safety Reporting

Pharmacovigilance Regulations

MedDRA Knowledge

Data Interpretation

Communication Skills

Process Improvement

Education

Degree in Medicine

Degree in Biological Sciences

Degree in Nursing

Degree in Pharmacy

Tools

Safety Databases

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 [e-mail]

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.

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