This position will lead assigned Sarepta Pharmacovigilance (PV) quality management activities globally for all investigational and marketed Sarepta products.
This position requires a collaborative leader with strong systems-thinking and quality management skills. The incumbent will join the PV department reporting directly to the Director, Pharmacovigilance Quality Management.
Primary Responsibilities include :
- Facilitate strategic PV quality planning and quality cycle process
- Support mapping of new and existing PV processes using MS Visio
- Lead the implementation and maintenance of a comprehensive PV training program. Develop training curricula and content for PV, internal and external Sarepta stakeholders with PV responsibilities.
Act as PV expert trainer
- Manage projects using industry-standard project management methods
- Implement and maintain a PV self-inspection program including inspection readiness
- Represent PV in audits and inspections including direct interactions with auditors and inspectors
- Monitor Key Performance Indicators and metrics. Coordinate collation of data for management reports and score cards
- Monitor Sarepta and vendor PV compliance with applicable plans, standard operating procedures (SOPs), regulations and guidelines
- Review PV documented procedures, records, Pharmacovigilance Agreements, Safety Data Exchange Agreements, etc.
- Oversee and manage PV CAPA and deviation processes internally and with PV vendor
- Collaborate with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, Legal, etc.
in establishing and improving Sarepta PV processes
- Identify, analyze, and implement opportunities for continuously improving Sarepta PV processes and systems
- Support the Director, Pharmacovigilance Quality Management with developing and implementing appropriate PV processes and systems
Desired Education and Skills :
- Advanced degree in Biological Sciences, Nursing, or Healthcare Administration
- Minimum 8 - 10 years’ experience in PV Quality Management
- Strong systems-thinking, strategic planning and quality management skills
- Excellent oral and written communication skills
- CAPA, project, document and training management skills
- Ability to actively contribute to continual process improvement initiatives within GPV
- Experience with MS Visio
- Ability to build relationships and influence across disciplines and all levels
- Working knowledge and understanding of global regulations for safety and pharmacovigilance including FDA, EMA, and ICH guidelines
- Exhibits attributes congruent with Sarepta Behaviors : Patients First, Action, Unconventional Thinking, Talent, and Integrity
- Global experience is preferred
- Occasional travel may be required
LI-Remote
This position is remote. However, 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 $156,000 - $195,000 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.
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