Senior Manager/Associate Director, PV Scientist

Senior Manager/Associate Director, PV Scientist

We are seeking a detail-oriented and dedicated Sr. Manager/Associate Director Drug Safety Specialist to join our team (title commensurate with experience). In this role, you will play a key part in monitoring and assessing the safety of our products, ensuring compliance with global pharmacovigilance regulations and contributing to the safety operations activities with vendors and partners.  You will work closely with cross-functional teams to ensure that all safety information is accurately reported and managed, helping to uphold the highest standards of drug safety.

Responsibilities (including but not limited to):

• Resolve safety case queries in collaboration with clinical operations and vendors
• Ensure timely resolution and closure of safety cases
• Collaborate with partners on safety data exchange and monitoring, ensuring compliance with Pharmacovigilance Agreements
• Work collaboratively with the DM colleagues on SAE reconciliation between safety and clinical databases
• Contribute to the preparation of DSURs, aggregate reports, and other regulatory documents as required
• Assist the PV physicians with safety surveillance, risk management, and risk communication for assigned products, participating in Safety Review Team (SRT) meetings and developing aggregate reports and other safety documents
• Attend product Safety Management Team (SMT) meetings and support SMT related activities (e.g., scheduling, preparing meeting minutes)
• Ensure that routine signal detection, assessment, and evaluation is completed and documented in a timely manner in collaboration with the PV physician
• Author and maintain SOPs as applicable
• Participate in audits and inspections related to drug safety activities, ensuring compliance with all applicable standards

Qualifications:

• Degree in biological or health-care discipline required. An advanced degree in a related field is a plus (e.g. MS, RPh, PharmD, etc.). 
• At least 4-6 years of experience in industry (biotech preferred) within Drug Safety & Pharmacovigilance with both investigational and marketed products.
• At least 3 years of experience with aggregate reporting, safety surveillance, signal management and/or risk management.
• Good understanding of the drug development process and context applicable to safety operation and surveillance activities.
• Excellent verbal and written communication and interpersonal skills.
• Ability to identify and resolve problems in a timely manner.
• Ability to manage multiple projects simultaneously while adhering to strict deadlines.
• Demonstrated accountability and a sense of urgency for both individual and team-owned projects