- The Director, Medical Review supports Global Pharmacovigilance with an emphasis on overseeing medical assessment of individual case safety reports from investigational and marketed product across all therapeutic areas.
- Responsible for overseeing high quality medical assessment of individual case safety reports in the Global Safety Database to ensure compliance with domestic and international regulations.
- Ensure effective communication with both internal and external stakeholders on individual case safety assessment related issues and prompt response to queries
location: Telecommute
job type: Contract
salary: $130.00 - 144.53 per hour
work hours: 9 to 5
education: Doctorate
responsibilities:
- Oversight of global medical review of individual case safety reports for company investigational and marketed products from all sources includes but not limited to the following:
- seriousness criteria confirmation and expectedness/listedness assessment
- review of the reporter's causality and company causality assessment
- event confirmation and coding as per convention,
- analysis of similar events as required,
- provide sound rationale in Company Comment regarding causality,
- ensure due diligence in adequate follow-up, and timeliness of expedited reports
- Collaboration with other PSPV personnel from other functions (AE processors, safety scientists and Global Safety Leads) in evaluating the safety profile of company products.
- Establish with alliance partners harmonization and industry standard medical review and case assessment standards
- Ensure effective communication with both internal and external stakeholders on individual case safety assessment related issues and prompt response to the queries
- Keep management informed of special concerns and developing safety problems with investigational compounds and marketed products
- Compliance, consistency and timely medical review
- Ensures complete and timely medical review to ensure accurate and compliant reporting of ICSRs to regulatory authorities globally within regulatory time frames.
- Partners with safety operations teams to ensure consistency of work practices and SOPs.
- Mentoring and training of new and or junior colleagues
- Work with the Head of Medical Safety Review to implement and augment onboarding and training processes
- Performs such other duties as requested by management
qualifications:
- Medical degree required or internationally recognized equivalent.
- USMLE/ECFMG/COMLEX-USA/FLEX preferred but not required.
- 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
- Demonstrate integrity
- Work productively in a high pressure environment
- understand/analyze/synthesize and communicate
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously
- Attention to details, computer literacy, 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 / coaching skills
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.
