Medasource
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Position: GPS Medical Review Advisor
Duration: 12-months
Location: Indianapolis/ Remote
Start Date: October 1st, 2024
Responsibilities:
1. Medical support of individual case adverse event reporting process
▪ Provide the medical and clinical expertise necessary to support Safety Management Associates and staff involved in
receiving, preparing, and reporting adverse events.
▪ Provide medical technical expertise in evaluation of adverse events, supporting the case management staff in
ensuring appropriate follow-up, reviewing assessments, and providing review for the medical content of Individual
Case Safety Reports (ICSRs) as needed, and making the determination of the sponsors’ assessment of relatedness
for applicable ICSRs.
▪ Work closely with the GPS Medical – therapeutic area group physicians and scientists to ensure appropriate
communication of safety issues (both locally and globally) and the medical quality of ICSRs.
▪ Identify or help support evaluation of potential quality issues with client products that may adversely affect patient
safety.
▪ Assist in supporting customer response activities associated with adverse events.
▪ Assist safety surveillance teams in review of specific individual ICSRs, bringing clusters of ICSRs from clinical trials
suggesting a safety signal to the attention of Safety Surveillance Teams (SSTs), understanding case management
specific issues and regulatory constraints, and conveying to the remainder of the Global Medical Review Group
compound or trial specific issues and concerns.
▪ Build collaborative working relationships with other physicians and scientists in GPS Medical to ensure full cooperation
and high-quality medical evaluation of safety data for global regulatory purposes.
▪ As requested, participate in process development, quality review, continuous inspection and audit preparedness and
support, and similar activities in response to a changing regulatory environment or corporate priorities.
▪ Act as a Medical Review representative for both internal and external customers, interacting as described in corporate
guidelines and policies.
▪ Build strong relationships with key customers, representing and championing the role of safety in the organization.
▪ Have a strong foundational knowledge of pharmaceutical industry, including understanding of relevant aspects of the
regulatory, industry, and scientific environments, laws, regulations, and guidance.
▪ Understand the roles and responsibility of the European Union Qualified Person for Pharmacovigilance (QPPV).
▪ Ensure support is provided to enable the QPPV to fulfil the QP legal responsibilities.
• Maintain medical expertise in areas of interest or specialty.
• Understand and comply with all compliance policies, laws, regulations, and the Red Book.
• Adapt to the changing global regulatory environment.
• Understand the confidential nature of company information and take necessary steps to ensure its protection.
• Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company
information to outside parties.
• Ability to work in a global environment (virtual tools and travel).
• Excellent teamwork skills.
Initial part-time training for 2-3 months for 16-20 hours per week. Due to variable adverse event reporting volume,
schedule will flex from 8-20 hours per week with opportunity for up to 40 hours per week with advanced notice, as
needed to support company business.
Qualifications:
- Physician – MD or DO
- extensive clinical experience – 10+ years
- Pharmacovigilance and Regulatory Experience
- Safety / adverse event reporting (ICSRs)
GPS Medical Review Advisor Indianapolis, IN
For over 16 years, Medasource has established and maintained relationships that are designed to meet your IT staffing needs. Whether it’s contract, contract-to-hire, or permanent placement work, we customise our search based upon your company’s unique initiatives, culture and technologies. With our national team of recruiters placed at 21 major hubs around the nation Medasource finds the people best-suited for your business. When you work with us, we work with you. That’s the Medasource promise.
Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
Benefits & Perks:
Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
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