Pharmacovigilance and Patient Safety Associate

Veristat; Northern (KY); Hybrid; USD 74,000 - 85,000; Full time

Benefits offered by this job

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat is seeking a Pharmacovigilance and Patient Safety Associate to manage SAEs/AEs and oversee patient safety matters across studies. The role collaborates with sponsors, investigator sites and internal teams to ensure proper collection and reporting of safety information.

The candidate will help develop training programs, support regulatory compliance, and assist the safety group leadership with day-to-day activities and mentorship.

Qualifications

• Bachelor’s degree in science or related field required; advanced degrees (PharmD, MD) strongly preferred.
• 2-4 years of pharmacovigilance/drug safety experience in CRO/pharma/clinical trials.
• Proficient with ICH GCP guidelines and regulatory rules; medical terminology and clinical research knowledge.
• Excellent project management, written and oral communication, organizational and interpersonal skills.

Responsibilities

• Process and manage serious adverse events (SAEs) and adverse events (AEs).soversee patient safety matters for study participants.
• Collaborate with sponsors, sites, and internal teams to collect and report safety information.
• Develop and implement training programs related to safety information.
• Assist department head in managing safety group activities and mentoring team members.

Skills

Project management

Written & verbal communication

Team leadership

ICH GCP familiarity

Safety databases familiarity

English proficiency

Education

Bachelor’s degree in science or related field

Advanced degree (PharmD/MD) preferred

Tools

Safety databases

Job description

**Job Description:****Pharmacovigilance and Patient Safety Associate**The Pharmacovigilance and Patient Safety Associate is responsible for the processing and management of serious adverse events, and the oversight of study patients’ safety matters. They work closely with other departments, sponsors, and investigator sites to ensure that proper plans are in place to appropriately collect and report information on Adverse Events (AEs) and Serious Adverse Events (SAEs).The Pharmacovigilance and Patient Safety Associate is responsible for facilitating the development and implementation of training programs for internal and external personnel involved in managing safety information. Additionally, they assist the department head in managing the relevant activities of the safety group.**Make an Impact at Veristat!**Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.* 105+ approved therapies for marketing applications prepared by Veristat* 480+ oncology projects in the past 5 years* 350+ rare disease projects delivered in the past 5 years* Flexible, inclusive culture — 70% remote workforce, 66% women-led teams* Learn more about our core values here!**What we offer:**The estimated hiring range for this role is $74K – 85K plus applicable bonus. This hiring range is specific to the USA and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.* Benefits vary by location and may include: + Remote working + Flexible time off + Paid holidays + Medical insurance + Tuition reimbursement + Retirement plans**What we look for:*** Bachelor’s Degree in a science or related field required; advanced degrees (PharmD, MD, etc.) strongly preferred.* 2-4 years of pharmacovigilance and/or drug safety experience in a CRO, pharmaceutical, or clinical trial environment required.* Proficient with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.* Excellent project management skills, written and oral communication, organizational, and interpersonal skills are required.* Familiarity with and ability to effectively utilize safety databases.* Proficiency in English (written and verbal) required.* Action-oriented and resilient in a fast-paced environment and with the ability to build and lead effective project teams, motivate others, delegate, and make and implement decisions.* Ability to build and maintain trust and confidence and communicate effectively with client, external vendors, and internal team members.* Ability to mentor and delegate.