Sr. Manager - Contract - Cambridge, MA (Remote)
Driving global patient safety through uncompromising pharmacovigilance excellence.
Proclinical is seeking a Senior Manager, Pharmacovigilance and QA to provide quality oversight of global post-marketing pharmacovigilance systems.
Primary Responsibilities:
The successful candidate will focus on ensuring compliance with Good Pharmacovigilance Practices (GVP) and other worldwide PV regulations, supporting audit programs, and contributing to inspection readiness activities. You will also collaborate with cross-functional teams and play a key role in maintaining and enhancing the quality framework for pharmacovigilance and post-marketing surveillance.
Skills & Requirements:
- University degree in life sciences or equivalent qualification/experience.
- Experience in the pharmaceutical industry within a quality or compliance function.
- Preferred experience conducting GVP audits.
- Knowledge of international GVP regulations, FDA PV requirements, Health Authority guidance, and ICH standards.
- Experience supporting Health Agency inspections.
- Self-motivated with a drive for continuous improvement.
- Strong interpersonal, verbal, and written communication skills.
- Ability to handle sensitive issues confidentially and professionally.
- Strategic thinker with the ability to analyze complex situations.
The Sr. Manager's responsibilities will be:
- Partner with expertise areas to enhance global pharmacovigilance systems and ensure compliance with GVP regulations, including procedural document reviews.
- Support non-interventional observational studies and post-marketing surveillance to meet regulatory requirements, considering Good Pharmacoepidemiology Practice (GPP) and Good Post-marketing Study Practice (GPSP).
- Contribute to cross-GxP QA activities requiring pharmacovigilance and post-marketing surveillance expertise.
- Execute global auditing processes for licensing partners, external vendors, internal audits, affiliates, and service providers in a post-marketing environment.
- Investigate quality events, evaluate root cause analyses, and determine corrective actions using risk-based thinking.
- Communicate and escalate critical matters to management effectively.
- Support the Global Strategic Audit Program by contributing to risk-based audit strategies, maintaining PV audit tools, and developing audit schedules.
- Provide QA audit, CAPA, and supplier data for the PV System Master File (PSMF) and ensure accurate data management processes.
- Develop tools and processes to support quality audit execution and outcomes.
- Lead inspection readiness and management activities for pharmacovigilance and post-marketing surveillance.
- Oversee PV and PMS-related vendor activities, including qualification assessments, quality agreements, and audits.
- Develop and report GVP QA metrics and dashboards to support quality oversight.
- Conduct training sessions for QA and expertise areas, maintaining the GVP QA Training Plan.
- Identify and propose process improvement opportunities and solutions.
- Perform other assignments as directed.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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