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Senior Lead, PV Science and Operations
Job Description:
- Manage internal PV personnel and external resources, including full oversight of all PV vendor activities to ensure operational excellence and compliance.
- Build (where applicable) and mentor a high-performing pharmacovigilance team, fostering a culture of scientific rigor, accountability, and continuous improvement.
- Oversee day-to-day case processing and global safety monitoring activities for assigned products across all phases of clinical development.
- Ensure timely, accurate assessment and reporting of adverse events and emerging safety signals.
- Lead and facilitate cross-functional safety governance meetings, including coordination of materials, agenda planning, data presentation, documentation of decisions, and tracking safety-related action items.
- Provide PV subject matter expertise on Program Teams and cross-functional working groups throughout the company.
- Contribute to the development and maintenance of core PV and safety governance documents, including Safety Management Plans (SMPs), safety data exchange agreements (SDEAs), and PV-related SOPs, work instructions, and process guides.
- Drive continuous improvement and inspection readiness across PV processes.
- Support strategic benefit-risk assessments and safety communication planning.
Requirements:
- Bachelor's degree required with at least 10 years of industry experience, including a minimum of 8 years focused on clinical/safety and demonstrated PV expertise
- Professional health background (RN, PharmD, MD) highly preferred.
- Knowledge of global safety regulations, MedDRA terminology and its application, and principles of data entry and data extraction with global safety databases.
- Experience reviewing cumulative safety data with the ability to interpret, synthesize, communicate, and present complex clinical/pharmaceutical information.
- Demonstrated experience in the preparation and authoring of pre- and post-aggregate safety reports.
- Thorough understanding of the drug development process and context applicable to safety surveillance activities.
- Ability to execute and follow through to completion.
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
- Ability to alert the Medical Safety Physicians or Medical Monitors to potential safety issues identified through single case medical review or aggregated datasets.
- Independently motivated, detail-oriented, and possessing good problem-solving ability.
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
- Excellent written and verbal communication skills and ability to influence across multiple functions.
- Ability to assist with first line clinical/medical data review to support medical monitoring activities.
Benefits:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
