Associate Scientific Director Pharmacovigilance & Clinical Safety

Alphanumeric•Rtp, NC

2d•Remote

About The Position

Alphanumeric Systems is seeking an experienced Associate Scientific Director - Pharmacovigilance & Clinical Safety to support the Global Safety organization of a leading pharmaceutical company. This position focuses on Safety Evaluation and Risk Management (SERM) across clinical development and post-marketing activities. The successful candidate will provide scientific expertise in evaluating emerging safety signals, interpreting complex clinical and safety data, contributing to benefit-risk assessments, and developing scientifically sound safety recommendations. Working closely with Medical Directors, Scientific Directors, regulatory professionals, and cross-functional safety teams, you will contribute to product safety strategy, Health Authority responses, regulatory submissions, and safety governance activities. This is an excellent opportunity for an experienced Safety Scientist or Pharmacovigilance professional who enjoys hands-on scientific analysis and wants to contribute to global patient safety.

Requirements

Bachelor's degree or higher in a Health Sciences or Healthcare Professional discipline, such as Pharmacy, Nursing, Biomedical Sciences, Medicine, or a related scientific field.
Substantial experience in pharmaceutical or biotechnology pharmacovigilance, clinical safety, drug safety, or safety evaluation and risk management.
Hands-on experience evaluating safety signals and interpreting clinical and/or post-marketing safety data.
Experience authoring or contributing to scientific safety assessments, aggregate safety reports, regulatory submissions, or Health Authority responses.
Understanding of benefit-risk assessment, safety risk management, and pharmacovigilance principles.
Knowledge of international pharmacovigilance regulations and guidelines, including ICH, GVP, and CIOMS.
Strong scientific writing, analytical, problem-solving, and communication skills.
Experience collaborating across multidisciplinary teams in a matrix organization.
Ability to manage competing priorities and deliver high-quality scientific work within regulatory timelines.

Nice To Haves

Advanced degree such as PharmD, PhD, MS, MPH, or equivalent.
Experience supporting FDA, EMA, or other global Health Authority safety inquiries.
Experience with both clinical development and post-marketing product safety.
Participation in Safety Review Teams, safety governance committees, or cross-functional benefit-risk discussions.
Experience in a global pharmaceutical or biotechnology environment.
Oncology, immunology, rare disease, or other therapeutic-area experience is beneficial but not required.

Responsibilities

Perform signal detection, evaluation, and ongoing safety surveillance for assigned pharmaceutical products across clinical development and post-marketing settings.
Analyze and interpret clinical trial data, post-marketing safety information, medical literature, and other relevant sources to identify and characterize potential safety risks.
Develop scientifically supported safety assessments, benefit-risk evaluations, and recommendations for risk characterization, mitigation, and communication.
Author or contribute to the safety components of global regulatory submissions, including responses to Health Authority inquiries.
Support the development and review of periodic safety reports, including DSURs, PSURs/PBRERs, Risk Management Plans (RMPs), and related safety documentation.
Collaborate with product physicians and cross-functional teams to ensure accurate and timely regulatory safety reporting.
Participate in Safety Review Teams and safety governance activities, including presenting complex safety findings and recommendations to senior stakeholders.
Support the evaluation and implementation of risk-reduction measures in clinical study protocols, product labeling, and other safety communications.
Partner with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, and Pharmacovigilance colleagues to address emerging safety issues.
Contribute to process improvements, regulatory compliance, and pharmacovigilance quality initiatives.
Provide scientific guidance and support to colleagues within a global matrix environment.