The Director, Medical Review supports Global Pharmacovigilance by overseeing high-quality medical assessments of individual case safety reports (ICSRs) across all therapeutic areas. This role ensures compliant, timely safety reporting in alignment with international regulations and fosters effective internal and external stakeholder communication.
location: Cambridge, Massachusetts
job type: Contract
salary: $130 - 144 per hour
work hours: 9 to 5
education: Doctorate
responsibilities:
- Global ICSR Medical Review: Oversee global medical review of ICSRs for investigational and marketed products. Ensure accurate seriousness confirmation, expectedness/listedness assessment, event coding, and provide sound rationale in Company Comments regarding causality and expedited reports.
- Cross-Functional Collaboration: Partner with AE processors, safety scientists, and Global Safety Leads to evaluate safety profiles. Communicate effectively with internal/external stakeholders and alliance partners to harmonize industry-standard case assessment guidelines.
- Compliance & Regulatory Timeliness: Ensure complete, timely medical review for accurate and compliant reporting of ICSRs to global regulatory authorities within required timeframes; partner with safety operations to align work practices and SOPs.
- Mentoring & Training: Collaborate with the Head of Medical Safety Review to implement and augment onboarding and training processes for new or junior colleagues.
qualifications:
Required:
- Medical degree or internationally recognized equivalent.
- Minimum 10 years pharmaceutical or health care related industry experience.
- 5 years clinical experience with patients following post-graduate training with significant knowledge of general medicine.
- Minimum 5 years experience in Pharmacovigilance including medical review of individual case safety reports.
- Multi-tasking with the ability to successfully manage multiple critical issues simultaneously.
- Knowledge of safety database.
- Take initiative in collaboration with management
- Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills, assertiveness, team spirit, and coaching skills.
- USMLE/ECFMG/COMLEX-USA/FLEX.
skills: Pharmacovigilance, Adverse Event (AE) Reporting, Individual Case Safety Report (ICSR), Medical Review of Cases
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
