Senior Director, Drug Safety & Pharmacovigilance
Location: Carlsbad, California US
Job Id: 511
Position Title: Senior Director, Safety
At Agility Clinical, we are a team of clinical trial experts who are dedicated to the success of our clients, so that ultimately patients can receive much-needed treatments. We believe the success of a company is much more about what it does every single day and how it does it, than about its revenues. From the beginning, we have nurtured a culture where patients’ needs and the needs of our valued clients come first, where the quality of our work is the best, and where our employees can thrive, while still having fun and giving back to the patient community. We are very proud of the team at Agility and what it has achieved thus far.
We are pleased to share this exciting opportunity for a Senior Director, Pharmacovigilance who is passionate about rare and orphan disease to join our growing business. As a member of our Senior Management team, you will have a blank slate when it comes to leading, developing and growing a new and innovative department.
Key safety services components focus will be on line management oversight, resourcing, business development, client project work and ARGUS.
- You enjoy variety and knowing that no two days will ever be the same
- You love seeing what you do every day impacts the lives of patients
- You are a self-starter and enjoy taking calculated risks and pushing the boundaries of what others believe is possible
- You are open-minded and always ask inquisitive questions that help you see things from various viewpoints and perspectives
- You put your big-picture thinking and differentiating insights into effect daily
- You successfully develop and cultivate relationships with business partners. Motivating and leading teams effectively comes natural to you
Here are some of the essential duties of the role:
- Handles the provision of safety services for clients in compliance with federal regulations, ICH guidelines, Good Clinical Practices, company Standard Operating Procedures (SOP) and client contractual arrangements
- Owns the multidisciplinary team completing the configuration, validation, and implementation process and the ongoing management of the related vendors and consultants for Argus and IRMS-AE
- Runs the day-to-day operations of the Safety group and the safety case managers, e.g., preparing and delivering annual performance reviews; coaching and mentoring
- Prepares for and participates in business development activities including attending bid defense meetings, proposal development and assigning of work
- Works with client and internal project teams to identify and address project safety needs from start‑up activities through completion
- Provides leadership, oversight and hands on assistance with safety case processing, preparation of project-related documents, safety tools, and safety information/tables and/or reports for clients and/or regulatory agencies
- Contributes to the development of internal processes including SOPs, Guidelines and Work Instruction Documents
- Provides consultation to clients or potential clients on safety requirements, including methods of safety data collection, processing, surveillance, and reporting for clinical studies and post-marketing projects
- Prepares and/or reviews narratives for clinical study reports (CSRs) and safety training materials
- Bachelor’s degree
- 12+ years of experience in safety in the CRO or pharmaceutical industry; minimum of 8 years in managerial role in drug safety
- Proven knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations
- Case processing in ARGUS and/or ARISg
- Supervisory experience
- Validated ability to challenge existing practices in order to become more effective.
- Ability to effectively adapt to a variety of situations. Works while meeting quality and performance standards. Strong influencing skills, communication skills; both written and oral. Works effectively as a team member and promotes teamwork. Shown ownership, initiative and accountability
- Approximately 20% travel
- Nursing or pharmacy degree
Division: Precision For Medicine
Business Unit: Oncology & Rare Disease
Employment Type: Exempt
Employment Status: Regular Full-time
Work From Home Available: No
Country: United States
Community / Marketing Title: Senior Director, Drug Safety & Pharmacovigilance
Country: United States
Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
EEO Employer Verbiage:
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
Location_formattedLocationLong: Carlsbad, California US