ProClinical is currently supporting a Biotechnology organisation based in Cambridge, MA who are seeking an experienced Pharmacovigilance Operations professional to join them at either an Associate Director or Director level. This is a newly created global position where you would be responsible for operations for clinical safety across many compounds as well products on the market.
- Provide safety and pharmacovigilance expertise in-house and by consultation with outside vendors for all development programs and marketed products. Ensure that all regulatory data collection and reporting requirements for individual case safety reports are clearly communicated and implemented.
- Collaborate with Regulatory Affairs to ensure appropriate reporting of PV and drug safety information to regulatory agencies and prescriber community.
- Oversee preparation and quality control activities for safety case processing activities performed internally and by vendors or contractors.
- Lead development of standard operating procedures for safety and internal compliance
Skills and Requirements:
- Health care degree in nursing or pharmacy with 10 years' experience in PV operations
- Ability to build relationships and influence across disciplines and all levels
- Global experience is required
- Occasional travel required.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Anna Graham on +1 646 542 0152 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.