Reporting to the CMO, the Vice President, Pharmacovigilance will be responsible for the strategic global implementation, execution, and management of Pharmacovigilance and risk management activities in conjunction with the Company's development and commercial activities, industry standards, and compliance with global regulations. They must effectively collaborate cross-functionally at all levels in the organization as well as external regulatory authorities. They will lead and provide medical oversight for the pharmacovigilance, drug safety and risk management functions for investigational and marketed products, ensuring proactive and timely risk-benefit assessments of safety data.

This individual should be a self-starter with excellent leadership and management capabilities who is seeking to be part of an innovative and fast-paced team to support the company's drug development activities.

Primary Responsibilities Include:

* Oversees and directs all aspects of pharmacovigilance and risk management activities for investigational compounds and marketed products; actively participates in oversight of patient safety in all clinical trials
* Designs, directs and conducts ongoing safety surveillance of company drug products using internal and external resources (CROs) to ensure delivery of high-quality pharmacovigilance services
* Negotiates contracts, interacts and supervises the activities of CROs and consultants for pharmacovigilance services. Provides ongoing updates to senior management on the changing risk-benefit profile of company drug products in clinical trials, based on analyses/evaluation of potential safety signals and implements appropriate safety updates and risk mitigation plans
* Provides strategic planning, implementation, and management of drug safety activities to support clinical development of company products
* Provides oversight of all clinical safety activities including review of medical coding of AEs, con-meds, and processing of SAEs through the entire lifecycle including preparation of analyses of similar events (ASE) for unexpected and related serious adverse events (SUSARs) from clinical trials
* Lead role to respond and resolve safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.
* Directs the development, preparation and compliance of periodic and annual safety reports (e.g., DSUR, PSUR, periodic line listings, NDA safety updates, etc...), investigator communications, product labeling/package inserts and other reports as necessary
* Provides medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs)
* Ensures departmental budgets and schedules meet corporate requirements
* Manage internal staff and external contractors to ensure delivery of quality safety and pharmacovigilance services, including selecting, developing, training, and evaluating team to ensure the efficient operation of the drug safety function
* Monitors industry best practices and changes in global safety regulations and guidelines. Recommends changes and upgrades to existing departmental policies, SOPs and systems to ensure global regulatory compliance

Desired Education and Skills:

* M.D. degree in health sciences is required
* Clinical expertise in rare disease preferred
* Minimum of 15+ years of progressive experience in Drug Safety in a biotechnology or pharmaceutical company required.
* Expert knowledge of FDA safety regulations, ICH Guidelines, EU GVP and other applicable regulatory guidance documents; expertise in global safety regulations
* Knowledge of U.S. and International Regulatory Reporting Requirements for Product Safety, and of the clinical development process.
* Expert knowledge of relational database applications (including ARGUS, ARISg, or other safety database).
* Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities
* Demonstrated ability to solve problems with innovative solutions along with strong organizational skills
* Possess strong and dynamic leadership skills, with excellent written, verbal and presentation skills
* Effective team player, fosters collaboration within and across functional areas
* Sound strategic evaluation, analysis, and decision-making skills
* Ability to work in a dynamic, fast paced environment
* Ability to balance competing interests of various stakeholders and strive for achieving mutually beneficial and compliant solutions

#LI-Hybrid

This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $320,000 - $400,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.