Medical Affairs Safety Manager Pv Science

Medical Affairs/Safety Manager PV Science Overview

• The Medical Affairs/Safety Manager PV Science role focuses on pharmacovigilance and safety risk management within the pharmaceutical industry.
• Collaborate with cross-functional teams to analyze safety data and manage safety signals effectively.
• Support the development and implementation of Safety Management Plans and Risk Management Plans.
• Contribute to the preparation of aggregate safety reports and regulatory documentation.
• Utilize signaling tools and global safety databases for data analysis and reporting.
• Work closely with safety leads to ensure compliance with global pharmacovigilance regulations.
• Provide expertise in interpreting clinical and safety data for decision-making.
• Participate in cross-functional meetings to present findings and collaborate on safety initiatives.
• This is a contract role with opportunities to contribute to impactful projects in drug safety.

• Analyze potential safety issues, including signal detection, evaluation, and management.
• Collaborate with study teams and external partners to address safety concerns.
• Perform signaling data reviews using tools like Empirica and clinical outputs.
• Assist in the development and evaluation of Safety Management Plans and Risk Management Plans.
• Prepare and present safety data analysis at cross-functional meetings.
• Contribute to the development of SOPs, guidelines, and templates for safety processes.
• Support authoring of aggregate safety reports such as PSURs and DSURs.
• Participate in safety committee activities, including documentation and action item follow-ups.
• Ensure readiness for regulatory inspections and compliance with global safety standards.

• Doctor of Pharmacy (PharmD) or equivalent healthcare-related degree is required.
• Minimum of 5 years of experience in pharmacovigilance or drug safety within the pharmaceutical industry.
• Proficiency in using signaling tools like Empirica and global safety databases.
• Strong knowledge of global pharmacovigilance regulatory requirements and safety processes.
• Experience in clinical development and post-marketing pharmacovigilance activities.
• Ability to interpret clinical and safety data for decision-making and reporting.
• Excellent communication skills, including presentation and documentation abilities.
• Experience in regulatory inspection readiness and compliance is preferred.
• Ability to work independently and collaboratively in a matrix environment.