Associate Medical Director Pharmacovigilance & Clinical Safety

Alphanumeric•Rtp, NC

2d•Remote

About The Position

Alphanumeric Systems is seeking an experienced Associate Medical Director - Pharmacovigilance & Clinical Safety to support the Global Safety organization of a leading pharmaceutical company. This position provides medical and scientific expertise in the evaluation, interpretation, and management of pharmaceutical safety information throughout clinical development and the post-marketing product lifecycle. As part of the Safety Evaluation and Risk Management (SERM) function, you will work alongside Medical Directors, Scientific Directors, and cross-functional safety teams to evaluate emerging safety concerns, contribute to benefit-risk assessments, support regulatory submissions, and develop evidence-based medical safety recommendations. The ideal candidate brings a strong medical background, substantial pharmacovigilance or clinical drug development experience, and the ability to translate complex clinical and safety data into scientifically sound assessments and regulatory communication.

Requirements

Medical degree (MD, MBBS, DO, or equivalent), or an appropriate equivalent healthcare qualification, such as veterinary medicine or dentistry, combined with relevant pharmacovigilance experience.
Relevant postgraduate medical or scientific qualifications.
Substantial experience in pharmaceutical or biotechnology pharmacovigilance, clinical safety, drug safety, or clinical drug development.
Experience evaluating safety information and contributing to the medical assessment of potential product risks.
Understanding of safety signal evaluation, benefit-risk assessment, and risk-management principles.
Experience preparing or contributing to medical/scientific safety documentation, regulatory submissions, or Health Authority responses.
Knowledge of international pharmacovigilance requirements, including ICH, GVP, and CIOMS guidelines.
Strong clinical judgment, medical writing, data interpretation, and analytical skills.
Experience collaborating with cross-functional teams in a global or matrix organization.
Ability to communicate complex medical safety findings clearly and develop evidence-based recommendations.

Nice To Haves

Prior experience as a Safety Physician, Drug Safety Physician, Medical Safety Scientist, or Associate Medical Director within pharmaceutical development.
Experience supporting FDA, EMA, or other global Health Authority safety inquiries.
Experience with both investigational and marketed pharmaceutical products.
Participation in Safety Review Teams, safety governance committees, or product benefit-risk discussions.
Experience supporting clinical protocols, investigator brochures, labeling changes, and regulatory safety documentation.
Therapeutic-area experience in oncology, immunology, rare diseases, or other pharmaceutical development programs.

Responsibilities

Provide medical and scientific expertise in the evaluation of safety data from clinical trials, post-marketing surveillance, medical literature, and other relevant sources.
Participate in signal detection, signal evaluation, and the characterization of emerging or potential product safety risks.
Conduct medically informed assessments of adverse events, safety trends, and potential risks associated with investigational and marketed pharmaceutical products.
Contribute to benefit-risk evaluations and develop recommendations for safety monitoring, risk mitigation, and risk communication.
Author or contribute to medical and scientific safety content for global regulatory submissions and Health Authority inquiries.
Support the preparation and review of aggregate safety documentation, including DSURs, PSURs/PBRERs, Risk Management Plans (RMPs), and related reports.
Collaborate with product physicians, safety scientists, and Regulatory Affairs colleagues to develop scientifically sound responses to regulatory safety questions.
Participate in Safety Review Teams and cross-functional safety governance discussions, presenting medical safety assessments and recommendations to senior stakeholders.
Evaluate potential implications of emerging safety information for clinical protocols, investigator brochures, product labeling, and risk-management activities.
Identify and escalate significant safety concerns to appropriate medical leadership and safety governance bodies.
Work collaboratively with Clinical Development, Medical Affairs, Regulatory Affairs, Biostatistics, and Pharmacovigilance colleagues.
Contribute to pharmacovigilance process improvements, regulatory compliance, and quality initiatives.