Director of Pharmacovigilance & Clinical Safety

Alphanumeric•Rtp, NC

12d•Remote

About The Position

Alphanumeric Systems is seeking an experienced Scientific Director - Pharmacovigilance & Clinical Safety to support the Global Safety organization of a leading global pharmaceutical company. This senior-level scientific role supports a Safety Evaluation and Risk Management function responsible for the scientific evaluation of safety information across products in clinical development and the post-marketing setting. The Scientific Director will evaluate and interpret complex clinical and safety data, assess emerging safety issues, support benefit-risk and risk-management activities, and contribute to global regulatory submissions and safety governance. A critical requirement is experience responding to Health Authority Requests for Information (RFIs) or similar regulatory queries. Candidates must have experience independently analyzing clinical and safety information and authoring scientifically sound safety responses, or substantive portions of responses, to Health Authorities such as the FDA, EMA, PMDA, or comparable regulatory agencies.

Requirements

Degree in a Health Sciences or Healthcare Professional discipline, such as BSc, MS, PhD, RN/BSN/MSN, NP, RPh/BPharm/PharmD, or a related field.
Extensive pharmaceutical or biotechnology industry experience in Pharmacovigilance, Drug Safety, Clinical Safety, Safety Science, or a closely related area.
Significant experience in safety evaluation and risk management involving clinical-development and/or post-marketing products.
Direct experience supporting Health Authority RFIs or regulatory queries, including independently authoring scientific responses or substantive portions of responses.
Strong understanding of clinical development and drug approval processes.
Knowledge of international pharmacovigilance requirements and standards, including ICH, GVP, and CIOMS.
Demonstrated ability to synthesize complex clinical and safety information and develop scientifically defensible conclusions.
Ability to work independently while recognizing when safety issues require escalation.
Demonstrated ability to work effectively within large, complex, global matrix organizations.
Strong scientific writing, verbal communication, and cross-functional collaboration skills.

Nice To Haves

Advanced degree in a relevant scientific or healthcare discipline.
Oncology clinical-development and/or oncology safety experience.
Experience supporting interactions with FDA, EMA, PMDA, or other major Health Authorities.
Experience with safety governance, signal evaluation, benefit-risk assessment, and risk-management planning.
Experience supporting global pharmaceutical development programs.

Responsibilities

Provide in-depth scientific expertise in pharmacovigilance, clinical safety, safety evaluation, and risk management.
Evaluate, synthesize, and interpret clinical-development and post-marketing safety data.
Assess emerging safety issues and contribute to ongoing benefit-risk evaluation for assigned products.
Independently author scientifically sound responses to Health Authority RFIs and regulatory safety queries.
Lead or support safety components of global regulatory submissions.
Develop and contribute to pharmacovigilance and risk-management strategies.
Participate in cross-functional safety governance and Safety Review Teams.
Recommend appropriate characterization, management, and communication of identified safety risks.
Provide safety input into clinical study protocols, product labeling, and other clinical-development activities.
Partner with Clinical Development, Regulatory Affairs, Medical Affairs, and other cross-functional stakeholders.
Recognize and appropriately escalate significant safety issues to senior leadership and safety governance.
Support regulatory inspections and inspection-readiness activities.