Associate Director, Safety Operations

Role Summary

Associate Director of Safety Operations, reporting to the Director of Safety Operations, will routinely solve complex project management issues while assisting with the oversight of the daily operations of the Olema Safety team as well as manage safety reporting compliance.

Responsibilities

• Ensuring timely and accurate processing of safety reporting to regulatory authorities, investigators, ethics committees, and business partners as applicable, within regulatory and business partner‚Äôs timelines and according to departmental standard operating procedures (SOPs)
• Managing safety reporting compliance
• Drafting and reviewing pharmacovigilance documents
• Preparing metrics related to safety reporting and reporting to upper management as needed
• Collaborating with cross functional teams (Clinical Operations, Data Management, Biostatistics); participating in meetings and teleconferences with cross-functional teams, CROs, and business partners
• Managing vendors, audit and inspection readiness and implementation, pre-launch activities, pre-commercial and commercial launch, manage NDA safety operations
• Assisting with study start up and management of new/future studies
• Spearheading the development of departmental systems including SOPs and departmental guidelines
• Performing SAE Reconciliation
• Training internal and external groups in Pharmacovigilance principles and best practices
• Working with safety vendor for daily operations tasks and implementing key action items

Qualifications

• Required: BA/BS degree in life sciences, pharmacy, nursing, or related degree
• Required: Previous experience with drug safety databases
• Experience: A minimum of 7-10 years of pharmaceutical industry experience, of which 5 years have been safety experience
• Experience: Broad clinical/medical knowledge, pharmacovigilance expertise, and technical system proficiency
• Experience: Excellent understanding of good pharmacovigilance practices and current global pharmacovigilance regulations, clinical trial methodology, and Good Clinical Practices (GCP)
• Experience: Strong presentation, communication and interpersonal skills; strong oral and written communication skills
• Experience: Managing external vendors as well as audit and inspection readiness, pre-commercial, commercial launch readiness
• Experience: Strong organizational, project management, technical and problem-solving skills
• Attributes: Ability to work independently, initiative, flexibility
• Attributes: Continually seek opportunities to improve processes and systems related to drug safety
• Attributes: Maintain confidentiality and adhere to ethical standards
• Attributes: Strong verbal and written skills and cross-collaboration skills

Skills

• Pharmacovigilance principles and best practices
• Safety reporting processes and regulatory compliance
• Vendor management and audit/inspection readiness
• Cross-functional collaboration
• SAE reconciliation

Education

• BA/BS in life sciences, pharmacy, nursing, or related field

Additional Requirements

• Role may be based in San Francisco, CA or Boston, MA; travel up to 5%