Drug Safety Lead

Organon • Jersey City, NJ

265d • $152,300 - $259,200

About The Position

The Drug Safety Lead leads signal detection, safety evaluation, and risk management planning and activities for low-medium complex medicinal products and/or medical devices during clinical development and/or for established brands from a scientific perspective. This role involves active participation and contribution to various safety-related decision-making governance bodies, ensuring patient safety and effective risk management strategies. The Drug Safety Lead is responsible for the safety contributions to global regulatory submissions and must demonstrate confidence, credibility, and influence at all levels of the organization. The position requires expert evaluation for literature review, clinical data synthesis, analysis, and interpretation, ensuring that scientific safety assessments are driven by comprehensive and customer-focused strategic patient safety expertise.

Requirements

• 3-5 years of pharmacovigilance experience in the pharmaceutical industry.
• Expert knowledge in pharmacovigilance methodologies in a global environment.
• Excellent analytical skills to evaluate, interpret, and present safety data.
• Fluency in English with highly effective communication and influencing skills.
• Excellent knowledge of international regulations (ICH, GVP/Volume 10, FDA regulations, GCP).
• Good computer literacy with experience in safety databases and IT systems.
• Ability to prioritize tasks and consistently deliver on deadlines.

Nice To Haves

• Sound knowledge and/or experience in related disciplines such as Pharmacoepidemiology, Pharmaceutical Medicine, Clinical Research.
• Experience in Medical Device product quality regulations and safety monitoring.
• MD-degree with clinical experience, ideally in Woman's Health, Internal medicine, or Pharmaceutical Medicine.

Responsibilities

• Accountable for signal management of assigned products, timely handling of signal evaluations and benefit/risk assessments.
• Responsible for CCDS/CCSI and key local labels safety sections.
• Lead risk management planning (RMP) and Additional Risk Minimization Measures (ARMM) development and execution.
• Create Aggregate Safety Reports (ASR) and Risk Management Plans (RMP) ensuring data completeness, accuracy, and timely submission.
• Evaluate strategies and RMST presentations, ensuring adequate documentation.
• Contribute to Technical Review Committee (TRC), Developmental Review Committee (DRC), and other relevant activities.
• Support Clinical Development/Regulatory Affairs/Affiliates on ad hoc questions concerning medical/clinical safety.
• Ensure timely investigation of emerging safety issues or significant safety signals.
• Collaborate with Clinical Operations and involved CROs for safety relevant information exchange.
• Oversee compliance of safety-related programs and registries.

Benefits

• Retirement savings plan.
• Paid vacation and holiday time.
• Paid caregiver/parental and medical leave.
• Health benefits including medical, prescription drug, dental, and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Master's degree