General Scope and Summary
SAGE Therapeutics is searching for an experienced Associate Director/Director Pharmacovigilance Scientist (AD/D PV Scientist) that is a creative, resourceful and integrative thinker. The person in this role works closely with the Global Safety Lead (GSL) and with the VP of Drug Safety and Pharmacovigilance and provides pharmacovigilance and signal detection expertise through contributions to clinical and post market pharmacovigilance deliverables and activities. Effective communication skills will be key as this role provides an excellent opportunity for close collaboration with colleagues from other functions such as Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs. The AD/D PV Scientist will provide scientific/clinical expertise, strategic input, and support for deliverables and activities associated with signal management activities, safety and benefit-risk evaluations for assigned products, management of potential safety issues for assigned products, evaluation of databases for safety signals, and drafting of responses to regulatory inquiries on product safety issues including oversight of aggregate reporting for all products within the product group.
Roles and Responsibilities
- Overseeing aggregate reporting, clinical trial activities, signal management, literature review, and ad hoc regulatory responses for assigned product group
- Lead product safety surveillance activities for assigned product(s)during all phases of the product life-cycle
- Review study protocols, statistical analysis plans and other clinical study-related documents
- Review standard design of tables, figures, and listings for safety data from clinical studies
- Manage updates to Investigator Brochure, Company Core Safety Information and other Reference Safety Information
- Signal detection, evaluation, and management
- Implement signal detection strategy approved by GSL and VP of Drug Safety and Pharmacovigilance
- Review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
- Prepare review of potential safety signals for GSO and VP of PVRM
- Provide safety contents for risk management plans
- Assisting in the successful implementation, execution and maintenance of safety processes and systems that conform to the company’s business strategy, industry standards and compliance with global regulations
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- Advanced degree (RN, PharmD, NP, PhD, MD, MPH, NP, DVM with specialty board certification)
- Minimum 6-8 years pharmacovigilance experience, including experience in aggregate safety reports and safety signal management.
- Expertise in the following; Argus Safety Database, MedDRA, Sharepoint, Microsoft Office, Excel
- Sound clinical acumen and decision making
- A proactive and innovative approach and a flexible, hands-on nature that works with a high sense of urgency.
- Ability to review, synthesize and analyze and communicate (verbally and in writing) complex safety data and clinical/pharmaceutical information
- Expertise in international regulations governing drug safety (US and EU) for pre and post-marketing
- Demonstrated leadership and collaborative skills necessary to influence across functions and earn credibility across a complex and rapidly growing organization.
- Level will be commensurate upon experience and qualifications.
- Excellent oral and written communication skills
- Prior experience contributing to the development (process improvement, training, etc.) of a drug safety would be desirable
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
- Excitement about the vision and mission of Sage