Job Title: Associate Director, PV Scientist Consultant (Part time-20 hours)

Work Location: MA OR Remote EST/CST

Summary:

This part-time contract role (20 hours/week, 6 months) focuses on providing expert pharmacovigilance support for clinical development programs, including safety analysis, signal management, and aggregate safety reporting. The position requires strong collaboration, leadership, and communication skills within a dynamic and creative team environment.

Responsibilities:

• Lead the creation and management of aggregate safety reports, ensuring timely and accurate documentation for clinical and post-marketing activities.
• Represent safety science in clinical study teams, supporting literature reviews and rapid responses to safety data requests.
• Participate in protocol design, safety monitoring plans, DSMB/DMC activities, and review of clinical study documents and safety data presentations.
• Develop and implement strategies for in-house aggregate reporting, literature surveillance, and risk management plans, including REMS activities.
• Oversee safety signal management, including documentation, signal tracker maintenance, and coordination of safety queries and evaluations.
• Ensure compliance with evolving pharmacovigilance regulations, including tracking/reporting of anticipated SAEs and SARs, and support inspection readiness.
• Collaborate closely with cross-functional safety and medical teams to support ongoing and new clinical programs in CNS indications.
• Contribute to the development and maintenance of safety processes, systems, and documentation aligned with industry standards and regulatory requirements.

Qualifications:

• RN, PharmD, NP, MD, MS, or DVM degree required.
• Minimum 8 years of experience in drug safety or pharmacovigilance scientist roles.
• Experience working on the sponsor side is required.
• Demonstrated expertise in safety surveillance, aggregate reporting, case management, and global regulatory processes.
• Strong knowledge of pharmacovigilance, clinical trial safety regulations, post-marketing safety, case processing, expedited reporting, and safety databases.
• Proven ability to analyze and interpret medical and scientific data.
• Excellent organizational, project management, leadership, written, and verbal communication skills.
• Experience with CNS therapeutic areas is a plus.
• Ability to work collaboratively in a creative, growth-oriented team environment.

Published Category: Pharmacovigilance