Pharmacovigilance and Patient Safety Associate

Veristat

Massachusetts

Hybrid

USD 74,000 - 85,000

Full time

4 days ago
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Benefits offered by this job

Remote working
Flexible time off
Paid holidays
Medical insurance
Tuition reimbursement
Retirement plans

Job summary

Veristat in Massachusetts is seeking a Pharmacovigilance and Patient Safety Associate to oversee processing of serious adverse events and safety matters for study participants. The role collaborates with sponsors, investigators, and internal teams to ensure accurate AE/SAE collection and reporting.

Ideal candidates hold a bachelor’s degree in science, 2–4 years in pharmacovigilance, strong knowledge of ICH GCP, excellent communication, and the ability to mentor others.

Qualifications

  • Bachelor’s Degree in a science or related field required.
  • 2–4 years pharmacovigilance/drug safety experience in CRO/pharma/clinical trials.
  • Proficient with ICH GCP guidelines and regulatory rules; medical terminology knowledge.
  • Excellent project management, written and verbal communication, organizational and interpersonal skills.
  • Familiarity with safety databases; English proficiency required.
  • Ability to mentor and delegate in a fast-paced environment.

Responsibilities

  • Process and manage serious adverse events (SAEs) and safety matters.
  • Collaborate with sponsors, investigators, and internal teams to collect and report AE/SAE information.
  • Assist department head in overseeing safety group activities.
  • Lead project teams and support mentoring of colleagues.

Skills

Project management
Written and verbal communication
Interpersonal skills
English proficiency
Team leadership

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 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).

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.

Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.

Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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