Senior Drug Safety Specialist, Pharmacovigilance Records & Compliance

  • Cambridge, MA
  • Posted 28 days ago | Updated 10 hours ago

Overview

On Site
Full Time

Skills

Document management
Attention to detail
Records management
Quality management
Continuous improvement
Pharmaceutical industry
Microsoft Word
IT service management
Regulatory Compliance
Mergers and acquisitions
Science
Policies
Management
Nursing
Pharmacy
Health care
Microsoft Excel
Adobe
Microsoft Visio
Communication
Network
Law
Apex
SAP BASIS
Innovation
Collaboration
Training
Recruiting

Job Details

Job#: 2022831

Job Description:

Senior Drug Safety Specialist, Pharmacovigilance Records & Compliance 2022831
Location: Cambridge, MA (Onsite)
Science: Small Molecule
Therapeutic Area: Oncology
Job Overview: In this role, you will be a key contributor to drug safety activities, focusing on records management and compliance to ensure tasks align with SOPs, policies, standards, and regulations.
Primary Job Responsibilities:
  • Support document management activities, including maintaining electronic files, and collaborating cross-functionally internal teams, CRO's, and vendors.
  • Contribute to the quality management of the Drug Safety system, ensuring department standards are met and implementing continuous improvement actions.
  • Participate in the daily management and execution of compliance activities, ensuring alignment with regulations, PV agreements, and internal SOPs.
Primary Job Requirements:
  • Bachelors degree in nursing, pharmacy, or a related healthcare field and have at least 2 years of experience in drug safety, pharmacovigilance, or a similar role within the pharmaceutical industry.
  • Demonstrated proficiency in working with Electronic Document Management System(s).
  • Proficient in using Microsoft Word, PowerPoint, Excel, Adobe, and Visio.
  • Strong communication skills, both oral and written, with the ability to analyze and problem-solve while maintaining exceptional attention to detail.

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

About Apex Systems