- A minimum of 2 years of experience in a pharmaceutical industry setting within Drug safety, Pharmacovigilance, or equivalent.
- Demonstrated experience with Electronic Document Management System(s).
- Proficiency in Microsoft Word, Power Point, Excel, Adobe, and Visio.
- Excellent oral and written communication skills.
- Strong analytical and problem-solving skills with superb attention to detail.
- Global pharmacovigilance operations experience with products in development preferred.
- Experience working with CROs, vendors, and other relationship management.
- Knowledge of FDA and EU legislation and ICH Efficacy guidelines.
- Proven track record working within a cross-functional, matrixed team.The Compliance Senior Drug Safety Specialist will:
- Assist the DSPV team with document management activities, including maintaining electronic files and collaborating with cross-functional teams.
- Aid in the quality management of the Drug Safety system, including ensuring department standards, training requirements, performance monitoring, and implementing continuous improvement actions.
- Engage in the daily management and execution of compliance activities.
- Support with document development requirements and align them to overall strategic objectives.
- Oversee DSPV compliance with regulations, PV agreements, and internal SOPs.
- Aid in sponsor oversight of AE/SAE processing by outsourced vendors, including the review and monitoring of compliance.
- Assist in maintaining a state of high PV inspection readiness across all regions/countries.
- Participate in regulatory inspections and company audits, including preparing responses to audit findings concerning the DSPV department. If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at (+1) or
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.
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Sr. Drug Safety Specialist, Compliance - Cambridge, United States - Proclinical
Description
Senior Drug Safety Specialist, Compliance - Contract - Cambridge, MA
Proclinical is on the lookout for a dedicated and experienced professional to fill the role of Drug Safety and Pharmacovigilance Compliance Specialist. This is a contract position located in Cambridge, MA.
Primary Responsibilities:
The successful candidate will be instrumental in drug safety activities, supporting records management and compliance across clinical development and marketing programs. This role is crucial in ensuring that operational activities align with industry standards, policies, and applicable regulations.
Skills & Requirements:
