Sr. Director, Global Pharmacovigilance Medical Director - Immuno-oncology
Greater Boston Area
Looking to get involved with one of the most novel areas in the life sciences, Immuno-Oncology? If you are a PV Physician, then look no further! We have partnered with a global biopharmaceutical company in its search for a Sr. Director, Global Pharmacovigilance Medical Director to head up its pivotal Immuno-Oncology programs to ensure successful submission to the FDA and other Health Authorities. In this role you will be given the autonomy to be a lead for these programs and you will have the final sign off and accountability for all products you are assigned to. This organization can be extremely competitive from a compensation perspective to entice you to make a move. If interested in learning more don't hesitate to apply.
The Sr. Director, Global Pharmacovigilance Medical Director - Immuno-oncology will be responsible for:
- Expectation of GSL role for compound(s) both in development and marketed in close association with the TAL.
- Company-wide safety expert for his/her 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.
- Serving in a leadership capacity for complex and strategically important programs
- 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 set up of safety procedures and development of safety exchange agreements for co-development projects.
- Maintain professional knowledge and accreditation by active participation in continuing medical education activities.
Ideal Candidates will have:
- MD, or foreign equivalent.
- Minimum 3 pharmacovigilance experience being a lead for post-marketed or clinical products.
