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Manager, Pharmacovigilance Operations

Employer
Parexel
Location
Romania
Salary
Competitive
Start date
14 Sep 2021
Closing date
14 Oct 2021

View more

Discipline
Medical Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Job Description

As a Pharmacovigilance Operations Manager you will manage and supervise project's PV Operations staff on a day-to-day basis, guiding performance of PV Operations staff in ongoing projects in terms of quality of deliverables, compliance with the timelines and relevant trainings. You will also provide process-related expertise for the various project specific activities including but not limited to processing of Individual Case Safety Reports, Signal and risk management, Regulatory operations and Medical writing, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs) and communicate with client for queries/feedback.

Key Accountabilities:
• Providing functional expertise/oversight of process and handling queries of the PV Operations staff
• Participation in meetings with client and within team, as needed.
• Performing activities delegated to the PV Operations staff in case of unplanned peaks or urgent requirements
• Prepare for and respond to internal/external audits/inspections
• Taking suitable action as per client feedback for any performance or process related concerns
• Providing project updates to the Senior Management on periodic basis
• Assisting his/her manager for operational day-to-day activities
• Maintaining up-to-date knowledge of relevant regulations and client's and Parexel's Standard Operating Procedures
• Coordinate with Solutions Consultant and/or regional Head of PV Operations as appropriate to assign resources to the project, and to assess staffing needs for current and future activities
• Ensuring to meet the requirements as in-Service Level Agreements and achieving all defined and agreed Key Performance Indicators in terms of quality, compliance and trainings
Qualifications

Skills and Experience required for the role:
• Degree in life Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.).
• A degree in Medicine/Dentistry/physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage.
• Considerable drug safety knowledge and experience
• Excellent knowledge of drug safety and the drug development process, and ability to interpret and apply global safety regulations
• Excellent team / project leadership and delegation skills, ability to train and mentor people
• Fluent English verbal & written
• Experience with computer applications including database management and Pharmacovigilance related computing systemsWhy Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

 

Company info
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB

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