Associate Director, Safety Operations

About the Role >>> Associate Director, Safety Operations

As the Associate Director of Safety Operations reporting to the Director of Safety Operations, you 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.

This role may be based out of our San Francisco, CA or Boston, MA office and will require 5% travel.

Your work will primarily encompass:

• Ensuring timely and accurate processing of safety reporting to regulatory authorities, investigators, ethics committees, and business partners as applicable, within regulatory and business partner's timelines and according to departmental standard operating procedures (SOPs)
• Managing safety reporting compliance
• Drafting and reviewing pharmacovigilance documents
• Preparing metrics, particularly related to safety reporting, and reporting to upper management as needed
• Collaborating with cross functional teams, Clinical Operations, Data Management and Biostatistics; participating in meetings and teleconferences with cross-functional teams, CROs, and business partners
• Responsible for 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

Ideal Candidate Profile >>>

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge

• BA/BS degree in life sciences, pharmacy, nursing, or related degree
• Previous experience with drug safety databases

Experience

• 7-10 years of pharmaceutical industry experience, of which 5 years have been safety experience
• Broad clinical/medical knowledge, pharmacovigilance expertise, and technical system proficiency
• Excellent understanding of good pharmacovigilance practices and current global (e.g., EU, US and Canada) pharmacovigilance regulations, clinical trial methodology, and Good Clinical Practices (GCP)
• Well-developed presentation, communication and interpersonal skills, and strong oral and written communication skills
• Must have experience managing external vendors as well as audit and inspection readiness, pre-commercial, commercial launch readiness
• Strong organizational, project management, technical and problem-solving skills

Attributes

• Ability to work independently, demonstrating initiative and flexibility
• Continuously seek opportunities to improve processes and systems related to drug safety
• Maintain confidentiality and adhere to ethical standards in all aspects of the job
• Strong verbal and written skills and demonstrated cross collaboration skills

The base pay range for this position is expected to be $195,00 - $210,00 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MT1