Global Pharmacovigilance Medical Director (Remote)
Greater Boston Area/Remote
A highly successful global biopharma organization is Global Pharmacovigilance Medical Director (Remote) to join their rapidly expanding team! This role will be focused on a large portfolio of well-established products. This organization's PV group is planning to expand their headcount by a minimum of 10 positions in 2021! This role is one of the few at this organization that have been approved to be remote permanently which can be hard to come by. There is also flexibility to upgrade this role to the Sr. director level for candidates that qualify. If interested in learning more don't hesitate to apply!
The Global Pharmacovigilance Medical Director (Remote) 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:
- , or foreign equivalent.
- Minimum 3 pharmacovigilance experience being a lead for post-marketed products.
