Drug Safety Associate
Proclinical is currently recruiting for a Drug Safety Associate with a biotechnology company located in Cambridge, MA.
- Maintain the MedDRA Expectedness Share Point site.
- Create, update and retire ETLs per departmental procedure.
- Create, update and retire Expedited lists per departmental procedure.
- Contribute to the maintenance of supporting related controlled documents and forms.
- Assist in the development of metrics and other key performance indicators
- Coordinate the biannual MedDRA up versioning activities for ETLs, Expedite/MedDRA Code lists, Custom MedDRA Queries (CMQs).
- Support the development of Safety's centralized CMQ process.
- Create, maintain and update a CMQ Library
- Assist in creating and maintaining controlled document for the CMQ process.
- Participate in the development of a centralized repository.
- Support the Medical Review Oversight weekly and monthly activities (SAE MRO assignments, running of NSAE MRO Reports, inputting SAE and NSAE findings into database, communicate findings to Vendors, perform trending and coordinate review meetings, compile and report the monthly metrics).
- Support the RSI ETL tracking process
- Research key regulatory and safety documents (Investigator Brochures; Core Data Sheets; Individual Country Labels).
- Track the ETL change history.
- Work with ICSR Medical Evaluation Senior Directors and Associate Directors supporting other activities as assigned.
Skills and Requirements:
- Minimum of bachelor's level degree in nursing, pharmacy, or other health care related profession or life sciences required
- Master's or Doctorate level degree in health care related profession preferred.
- 2+ years in drug safety/Pharmacovigilance in pharmaceutical industry setting or the equivalent.
- Experience with interacting with third parties (e.g., contract service providers) preferred.
- Knowledgeable in Pharmacovigilance and GCP legislation required.
- Direct experience in GXP compliant quality systems preferred.
- MedDRA Dictionary knowledge
- Excellent written and verbal communication skills including technical writing skills, PC skills, ability to produce clear, concise documentation and good analytical skills.
- Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
- Ability for individual decision-making required.
- Effective managerial skills, being a self-starter, ability to work independently, goal oriented, high level organization, attention to detail and accuracy, and ability to multi-task and prioritize.
- Must demonstrate initiative to identify and communicate issues within department and across departments.
If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.