What are the responsibilities and job description for the Pharmacovigilance Manager position at Actalent?
Description
- Serve as a primary liaison and point of contact for vendor operations and vendor oversight including vendors performing case management case intake i.e. Call Centers scientific literature review etc.
- Oversee operations performed by the PV BPO vendor including contract compliance quality and timeliness of deliverables.
- Serve as the primary liaison and point of contact for vendor operations including the PV BPO vendor and/or vendors performing case management case intake literature review call centers
- Provide Subject Matter expertise SME during audits and inspections in the areas of case processing/case management activities literature monitoring legal case processing vendor oversight etc.
Accountabilities:
- Provide leadership and oversight on case management for the Global PV Operations Team to ensure adverse event information is processed according
to company timelines and quality standards
- Oversee regulatory submissions for ICSRs from the Global Safety database on-time delivery of adverse event reports to global Health Authorities alliance partners local operating companies LOCs including SUSAR and SAE communication to ECs and investigators as applicable
- In partnership with the Global Standards and Compliance team direct and manage communication with alliance partners LOCs and CROs regarding the evaluation and processing of ICSRs
- In partnership with the Global Standards and Compliance team lead and direct the review and approval of alliance partner safety data exchange agreements for the inclusion of appropriate safety reporting requirements
- Ensure overall performance of the department and compliance with global regulatory requirements by implementation of appropriate SOPs processes metrics and monitoring of performance and compliance and training at a global level
- Oversee and direct reconciliation processes for case exchange with LOCs and alliance partners
Additional Skills & Qualifications
- Minimum 4 years pharmaceutical or health care related industry experience required.
- Minimum 3 years PV experience with 1 year experience working with CROs vendors and relationship management required
- Global experience with CROs vendors and relationship management preferred
Education:
- Bachelors required. Advanced degree in scientific/medical field preferred.
Pay and Benefits
The pay range for this position is $60.00 - $75.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully remote position.
Application Deadline
This position is anticipated to close on Mar 11, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $60 - $75
