PV Scientist

Proclinical is currently seeking a PV Scientist for a pharmaceutical company located in Cambridge, MA. Successful candidate will contribute to the day-to-day operational activities of the function PV-SQI and ensure that performed tasks comply with DS and PV SOPs and policies, best industry standards and applicable regulations.

Job Responsibilities:

• Monitoring compliance with regulations, PV agreements and internal SOPs.
• Representing Drug Safety and Pharmacovigilance on clinical development teams, as assigned.
• Providing sponsor oversight of SAE processing by outsourced vendors, including reviewing and monitoring of compliance through various monitoring reports and other oversight activities.
• Providing safety operations support for external submissions, signal detection and risk management planning activities.
• Participating in authoring of periodic safety reports.
• Ensuring compliant exchange of safety data between the client and its partners.
• Participating in the quality management system in Drug Safety.
• Working with QA department to maintain a state of high PV inspection readiness across all regions/countries.
• Collaborating with contract service providers for case processing, aggregate reporting and quality management activities.
• Managing performance of PV systems.
• Participating in regulatory inspections and company audits.

Skills and Requirements:

• BS in nursing, pharmacy, or other health care related profession or life sciences required.
• MA/MS/PhD in health care related profession preferred, but not essential.
• 2+ years of experience in drug safety/pharmacovigilance in a pharmaceutical industry setting or the equivalent.
• Global pharmacovigilance operations experience with products in development.
• Safety database, MedDRA coding and data entry experience.
• Knowledge of FDA and EU legislation and ICH Efficacy guidelines.
• Strong analytical and problem-solving skills with superb attention to detail.
• Strong verbal, written technical communication and presentation skills.
• Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization.
• Proven ability to work within a cross-functional, matrixed team.

To Apply:

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 Brandy Plumb at (+1) 646-367-2745 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.

#LI-BP1
#DrugSafety