Marinus Pharmaceuticals is a clinical stage biopharmaceutical company committed to developing breakthrough therapies to improve the quality of lives of patients and their families as they battle rare and life-threatening diseases.
Based in Radnor, PA we are a team of dedicated and talented professionals who value innovation and commitment to developing new therapies for CNS disorders and are passionate about making a positive difference in the lives of our patients.
We are currently searching for an experienced professional to join our team as a Sr Director/Director, Pharmacovigilance Operations
The Pharmacovigilance (PV) Operations Sr Dir/Director provides leadership in the areas of pharmacovigilance regulations/policies, PV operations, business capabilities, and innovation. The incumbent also oversees the implementation and monitoring of PV activities related to collection, processing, medical assessment and compliant reporting of PV information to regulatory agencies and business partners within each region (specifically US and EU) in accordance with PV regulations.
This role is accountable for the implementation of necessary processes to ensure compliance with regional regulations and global standardization. This role is responsible for supervising and engaging with a PV team which supports these processes and working cross-functionally to maintain global standards for pharmacovigilance activities to ensure patient safety
Key Responsibilities including, but not limited to the following:
- Sets Corporate direction for and lead global pharmacovigilance operations activities for ensuring Corporate compliance with all relevant Global PV Regulations and requirements for the processing of adverse events associated with sponsored drug products, including investigational and marketed compounds and in-licensed
- Establishes the Pharmacovigilance Operations Department direction, standards, and processes for supporting Corporate pharmacovigilance operations and will lead Innovation and strategy for the continuous enhancement of the PV systems in close collaboration with relevant stakeholders to ensure Global needs are met.
- Oversee and ensure the Pharmacovigilance business requirements are met. Drives strategic planning, roadmap and execution of the Pharmacovigilance Operations Department structure, reporting and analytics requirements from the Global Safety database and PV systems and ensure that Global PV regulatory requirements are met and support of relevant PV Business Partners
- Oversee the activities of the EU QPPV
- Lead the interaction with relevant internal or external functions for the Global PV operational function in inspections, and audits.
- Negotiate vendor contracts and agreements. Direct the global oversight for management of Global Pharmacovigilance Operations Service Provider(s).
- Monitor metrics related to individual case and aggregate safety reporting and ensure effective implementation of appropriate action plans by liaising with other stakeholders as appropriate to address compliance and quality issues.
- Accountable for implementation of new or updated regional regulations and/or ICH Guidelines regarding individual case and aggregate safety reporting.
- Collaborates internally and externally on processes that ensure compliance with regional and global PV regulations. Ensure the oversight of the PV Agreements and Safety Data Exchange Agreements with vendors, partners and others
Qualifications:
- Minimum Advance degree - PhD, Pharm D, Master's degree required. Degree in a life science/health care/pharmaceutical related field ideal.
- Minimum of 10 years of experience in the pharmaceutical industry with a specific focus on pharmacovigilance related activities
- Advanced proficiency in Microsoft Office applications (Outlook, Word, Excel, and PowerPoint) and other software
- Knowledge of current US and international pharmacovigilance regulations
- Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees.
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
- Solid project leadership/management skills
- Knowledge of global pharmacovigilance regulatory requirements and guidelines (EMA/541760/2011 Guideline on good pharmacovigilance practices (GVP), 21 CFR 314, for drug/medicinal/biologic.
- An advanced understanding of the drug development process, along with clinical trial methodology, GCP, and medical terminology
- Breadth and depth of experience managing pre-marketing and post-marketing PV
- Ability to apply technical, line, and business knowledge to contribute to the strategic direction of the Pharmacovigilance post marketing and development programs
- Detailed knowledge and experience using a global drug safety database, e.g. Argus
- Proficient scientific writing skills
- Up to 10% travel may be required based upon business needs.
At Marinus, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.
All employment is decided on the basis of qualifications, merit, and business need
Search Firm Representatives Please Read Carefully
Marinus Pharmaceuticals does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.