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We are seeking an experienced Director, Medical Reviewer, Contractor, to support our Client's Global Patient Safety & Pharmacovigilance team. This is a 6 month contract term at the moment. This role will focus on the medical review and assessment of individual case safety reports for investigational and marketed products across therapeutic areas.

The consultant will oversee high-quality medical assessment of cases in the global safety database, ensuring regulatory compliance with domestic and international reporting requirements. This includes reviewing seriousness criteria, expectedness/listedness, reporter and company causality assessments, coding accuracy, follow-up needs, expedited reporting timelines, and company comments.

The Director, Medical Reviewer will collaborate closely with safety operations, AE processing teams, safety scientists, Global Safety Leads, alliance partners, and other internal and external stakeholders. The role requires strong medical judgment, attention to detail, and the ability to manage multiple priorities in a fast-paced global pharmacovigilance environment.

Key Responsibilities:

• Perform and oversee medical review of individual case safety reports for investigational and marketed products.
• Assess seriousness, expectedness/listedness, causality, coding, event confirmation, and follow-up needs.
• Provide clear medical rationale in company comments and case assessments.
• Ensure timely and compliant reporting of ICSRs to global regulatory authorities.
• Partner with safety operations and cross-functional PSPV teams to support consistent work practices and SOP alignment.
• Communicate effectively with internal teams, external partners, and management regarding case safety assessment issues.
• Identify and escalate potential safety concerns or developing safety issues.
• Support onboarding, training, and mentoring of junior colleagues as needed.

Required Qualifications:

• Medical degree required, or internationally recognized equivalent.
• Minimum 10 years of pharmaceutical, healthcare, or related industry experience.
• At least 5 years of clinical patient-care experience after postgraduate training.
• Minimum 5 years of pharmacovigilance experience, including medical review of individual case safety reports.
• Strong knowledge of general medicine, safety databases, global regulatory expectations, and ICSR assessment.
• Ability to work independently in a remote environment while collaborating with global, cross-functional teams.

Preferred Qualifications:

• USMLE, ECFMG, COMLEX-USA, or FLEX preferred but not required.
• Prior experience supporting global safety databases and marketed/investigational products.
• Experience working with alliance partners and global pharmacovigilance stakeholders.

Ideal Candidate Profile:

The ideal candidate is a medically trained pharmacovigilance professional with deep ICSR medical review experience, strong clinical judgment, excellent communication skills, and the ability to operate effectively in a high-pressure global safety environment.