Offer summary

Qualifications:

Healthcare professional degree (i.e., RN, PharmD) or degree in life sciences or other health-related field., Knowledge of global safety regulations, ICH Guidelines, and applicable regulatory guidance documents., Strong interpersonal and communication skills, both written and oral., Proficiency in MS Office Suite and safety database experience preferred..

Key responsibilities:

Monitor and manage the safety inbox and update safety workflows.

Perform safety case management including tracking and data entry.

Liaise with safety physicians and other organizations on safety data issues.

Organize workload to ensure departmental workflow processes and timelines are followed.

Job description

We are looking for an experienced Drug Safety Associate I to join our team!

The Drug Safety Associate I candidate will work in a team-oriented, dynamic, and collaborative environment. This person will manage the drug safety mailbox, tracks case workflow, supports the drug safety activities while adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures. This position also ensures compliance with standard operating procedures, regulatory, safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA), World Health Organization, country, and regional regulations for the reporting of adverse events to regulatory agencies.

Remote applicant are welcome to apply.

Drug Safety Responsibilities:
• Monitor and manage the safety inbox, including archiving of emails and documents
• Update and manage various safety workflows as well as submission trackers
• Perform safety case management including receipt, duplicate check, tracking, assessment of seriousness and expectedness, and data entry
• Interpret case-related information including medical conditions, lab results, and procedures
• Review, enter, and verify follow-up information for cases
• Liaise with safety physicians, medical monitors, sites, vendors, or other organizations as needed on safety data issues
• Recognize situations that require assistance from more senior staff members or Safety Physicians and seek assistance from appropriate internal resources

General Responsibilities:
• Organize workload to ensure departmental workflow processes and timelines are followed
• Remain current with CPC SOPs, guidance documents and database technology
• May perform Quality Control on other team member’s work
• Able to work independently and prioritize workload
• Participate in other activities as needed

Qualifications:
• Healthcare professional degree (i.e., RN, PharmD) or degree in life sciences or other health-related field
• Knowledge of global safety regulations, ICH Guidelines, and other applicable regulatory guidance documents
• Strong interpersonal and communication skills, both written and oral
• Proficiency in MS Office Suite (Excel, PowerPoint and Word)
• Safety database and case processing experience preferred
• Cardiovascular experience or knowledge preferred
• Demonstrated initiative, teamwork and accountability
• Demonstrated success working both independently and in collaboration with others
• Great attention to detail, commitment to quality and accuracy
• Excellent organizational skills, and ability to adapt to change
• Ability to follow guidelines and procedural documents
• Ability to work independently

Note: Viable applicants will be required to pass a background and education verification check.

Targeted Compensation: $55,000 - $58,000 annually

Deadline to Apply: June 1, 2025

About CPC:

CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 35 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more.

CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.

CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. http://www.cpccommunityhealth.org/

CPC offers:

Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
11 paid holidays
15 - 25 vacation days based on years of service
Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
In-suite exercise and relaxation room
Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
Flexible and remote work schedules

An Equal Opportunity Employer

CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at careers@cpcmed.org.

Compensation$55,000 - $58,000

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