Assoc Medical Mgr PSS

We are seeking a medically qualified professional with strong pharmacovigilance expertise to support patient safety and the evaluation of adverse events associated with pharmaceutical products, medical devices, and combination products. In this full-time, fully remote role, you will conduct medical reviews of safety cases, assess potential risks, and ensure that case documentation meets regulatory and quality standards. You will contribute to post-marketing drug safety activities while applying your knowledge of clinical research, medical science, and global pharmacovigilance practices. Working closely with case processing teams, you will provide medical guidance, support quality assurance, and identify opportunities for continuous improvement. This position offers the opportunity to apply your clinical expertise in a collaborative, fast-paced environment focused on patient safety and regulatory compliance. The role is suited to a physician with substantial pharmacovigilance experience and a strong commitment to accuracy, quality, and effective teamwork.

• Medical Qualification: Medical degree (MD or DO) required. Relevant equivalent experience may be considered in lieu of educational requirements, subject to the employer’s assessment.

• Pharmacovigilance Experience: At least 4 years of pharmacovigilance experience, including clinical trial and post-approval experience.

• Drug Safety Expertise: Strong knowledge of adverse event assessment, case processing, medical review, drug safety, and pharmacovigilance practices.

• Medical Knowledge: Working knowledge of medical sciences, diagnosis, therapeutics, drug treatments, and clinical procedures.

• Regulatory Knowledge: Understanding of regulatory requirements for clinical research and pharmacovigilance, including International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines.

• US Healthcare Knowledge: Comprehensive understanding of the US healthcare system.

• English Proficiency: Strong English communication skills across speaking, writing, and reading.

• Attention to Detail: Ability to assess complex medical information accurately, maintain thorough documentation, and uphold high standards of quality and compliance.

• Organization and Accountability: Ability to manage multiple deliverables, meet deadlines, and maintain expected productivity and quality standards in a fast-paced environment.

• Preferred Clinical Credentials: Completion of an accredited medical residency program or equivalent, with board eligibility or certification.

• Preferred Industry Background: At least 4 years of pharmaceutical industry experience, particularly in pharmacovigilance, post-approval safety, case processing, medical review, and/or clinical research.

• Preferred Clinical Practice: 1–2 years of clinical practice experience.

• Preferred Specialized Expertise: Substantial knowledge of global pharmacovigilance regulations, drug safety, and risk management.