Job Title: Associate Director Clinical Operations Program Leader
Location: Remote
Job Summary: We are seeking a skilled leader to drive process development, oversight, and innovation in pharmacovigilance signal management. Our team is dedicated to maintaining the highest standards of patient safety and regulatory compliance within a global healthcare environment.
Responsibilities:
- Ensure full compliance with global pharmacovigilance and risk management regulations and guidelines to protect patient safety.
- Lead the development, implementation, and continual improvement of signal detection and management processes across cross-functional teams.
- Mentor and guide teams and junior scientists in signal management activities, process training, and the integration of advanced analytical tools, including AI/ML.
- Represent pharmacovigilance functions as a subject matter expert in both internal and external forums, maintaining standards and supporting audits and inspections.
Required:
- Graduate degree in health sciences, nursing, pharmacy, public health, epidemiology, or related field (MD, PhD, PharmD, NP, PA, pharmacy, or nursing degree) with a minimum of 5 years’ relevant experience.
- Strong skills in analyzing, interpreting, and presenting complex data, with experience in signal detection, risk/benefit analysis, and pharmacovigilance regulations for both US and EU markets.
- Expertise with safety data from clinical trials and other sources, aggregate safety reporting (DSUR, PSUR/PBRER, PADER), and development of safety documents for regulatory authorities.
- Proficiency in Microsoft Word, Excel, PowerPoint, and demonstrated ability to design advanced data analysis and visualization tools.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from SSi People and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: SSi People Privacy Policy