Junto HLS has been engaged by Leadership at a Top 20 pharma client to recruit a Senior Medical Director, Pharmacovigilance.
- Serve in a leadership capacity for complex and strategically important programs
- Support for compound(s) both in development and marketed in close association with the Therapeutic Area Leader (TAL)
- Companywide safety expert for compound responsibilities
- Intimate knowledge of safety, including any emerging safety concerns and risk/benefit profile for ‘own’ compounds with input for other compounds as needed.
- Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs etc
- Training and mentoring of Pharmacovigilance Physicians and Specialists
- Perform activities required to serve as Global PV physician:
- Review and oversight of safety data, both non-clinical and clinical
- Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities
- Interactions with external experts and regulatory agencies and partner/co-development companies
- Review of safety data and participate in dose escalation decisions
- Authorship and sign off of Safety Monitoring Plan/Risk Management Plan
- Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
- Direct the setup of safety procedures and development of safety exchange agreements for co-development projects
- Greater Boston, MA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.