Sr. Manager Product Safety & PV Operations
Our client, a leading vaccine development company, are in search for a Senior Manager of Product Safety and PV Operations for their Gaithersburg, MD location. We are seeking a motivated and experienced individual to coordinate and lead a variety of Pharmacovigilance (PV) activities with a primary focus on development and oversight of the necessary processes to ensure the collection, processing, and compliant reporting of individual case safety reports (ICSR) to regulatory agencies and business partners in accordance with global PV regulations.
- Development and management of post marketing ICSR processing and reporting SOPs, Work Instructions, and Templates.
- Oversee implementation and monitoring of processes pertaining to ICSR processing and reporting to regulatory agencies and business partners in accordance with PV regulations.
- Ability to develop and provide safety reporting training.
- Ability to direct and oversee an ICSR processing team, working cross-functionally to maintain standards for PV activities to ensure patient safety and adherence to global regulations.
- Performing critical team and/or vendor oversight to ensure all PV activities are performed in an efficient, consistent and compliant manner.
- Effectively collaborate with and support key internal and external cross functional stakeholders (Medical Affairs, Clinical, Regulatory, Business Partners, etc.) on clinical trials, investigator sponsored research programs, market research surveys, etc. to ensure PV compliance oversight.
- Support and participate in Signal Detection and Risk Management planning activities.
- Support and participate in Safety Review Team meetings.
- Work with PV Compliance to monitor KPIs, maintain PV inspection readiness, and act as subject matter expert during PV inspections/audits.
- Support Aggregate Reporting Teams with development of PBRERs, PADERs, DSUR, etc.
- Support Safety Data Exchange Agreement negotiations with Business Partners.
Skills and Requirements:
- Bachelor's Degree in scientific related field with minimum of 8 years of pharmacovigilance experience
- A proven track record in PV with several examples of leading postmarketing PV activities.
- Expert in MedDRA coding.
- Demonstrated ability to apply principles, concepts and industry best practices governing PV in assigned projects and company deliverables.
- In depth knowledge of global safety reporting activities, regulations, guidance, and ICH/GXP guidelines.
- Experience developing of SOPs, Templates, and Working Practices.
- Excellent written and verbal communication skills.
- Strong interpersonal skills and ability to manage, motivate and influence work behaviors of individuals who are not direct reports.
If you are having difficulty in applying or if you have any questions, please contact Nicole Aganon at (+1) 347-293-1161 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.