We are looking for an experienced Drug Safety Associate II to join our team!
The Drug Safety Associate II candidate will work in a team-oriented, dynamic, and collaborative environment. This person will be responsible for providing drug safety expertise and ensuring accurate and timely documentation of safety data, particularly serious adverse events (SAEs). This role will support all major tasks related to the management of case processing activities, ensuring compliance with global clinical safety and pharmacovigilance regulations.
Remote applicant are welcome to apply.
Drug Safety Responsibilities:
- Support all drug safety aspects of studies managed by CPC.
- Process and assess adverse events from receipt to case closure, including query generation and narrative writing.
- MedDRA and WHODrug coding, as needed.
- 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, data entry and narrative writing.
- Interpret case-related information including medical conditions, lab results, and procedures, as well as compile complete narrative summaries.
- Review data to ensure case accuracy with minimal error in narratives.
- Review, enter, and verify follow-up information for cases and make accurate determination of significant information.
- Perform review of ancillary documentation accompanying ICSR reports and identify pertinent information for incorporation into the case narrative.
- Correctly identify cases requiring targeted follow-up, and determine relevant follow- up queries.
- Meet specific data and quality targets for case handling.
- Liaise with safety physicians, medical monitors, sites, vendors, or other organizations as needed on safety data issues.
- Collaborate with other CPC departments (e.g., Research Operations, Data Management, etc.) to ensure appropriate collection and handling of safety data.
- Training of new safety staff on databases and case processing.
- Organize workload to ensure departmental workflow processes and timelines are followed.
- Support PV Audit and Inspection preparation as needed.
General Responsibilities:
- Identify and implement methods, techniques, procedures and evaluation criteria to achieve results.
- Perform a variety of complicated tasks with some degree of creativity and latitude.
- Remain current with CPC SOPs, guidance documents and database technology.
- Perform Quality Control on other team member’s work as needed.
- Participate in other activities as needed or as requested by the supervisor.
Qualifications:
- Healthcare professional degree (i.e., RN, PharmD) with minimum of 3 years professional experience or Bachelors’ degree in life sciences or equivalent relevant scientific qualifications with minimum of 3 years of experience in drug safety
- Knowledge of global safety regulations, ICH Guidelines, and other applicable regulatory guidance documents
- Experience using Argus safety database preferred
- Clinical trial and adverse event processing experience
- MedDRA training and experience
- Excellent interpersonal and communication skills, both written and oral
- Excellent proficiency in MS Office Suite (Excel, Power point and Word)
- Cardiovascular experience or knowledge preferred
- Ability to prioritize workload
- Ability to assess data and understand the medical/safety implications
- Demonstrated success working both independently and in collaboration with others
- Strong attention to detail, commitment to quality and accuracy
- Strong organizational skills and ability to adapt to change
- Ability to follow guidelines and procedural documents
Note: Viable applicants will be required to pass a background and education verification check.
Targeted Compensation: $64,000 - $76,000 annually
Deadline to Apply: September 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)
- 10 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)
- 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 [email protected].
