Vice President, Global Pharmacovigilance

Sarepta Therapeutics•Cambridge, MA

4d•$346,000 - $432,500•Hybrid

About The Position

Reporting to the CMO, the Vice President, Global 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. The Vice President 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.

Requirements

Minimum of 10+ 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
Candidates must be authorized to work in the U.S.

Nice To Haves

M.D. degree in health sciences is preferred
Clinical expertise in rare disease preferred

Responsibilities

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