Pharmacovigilance and Regulatory Affairs Specialist - Fort Washington, United States - PrimeVigilance

Description

Pharmacovigilance and Regulatory Affairs Specialist

Full-time

Department:
RA & PV Network

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008.

We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within:
Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field.

We cover all therapy areas including medical device.
We love investing in our staff by providing an excellent training and development platform.

We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient's lives.

The Specialist, Pharmacovigilance and Regulatory will assume leadership and functional representation for projects assigned and coordinate the local contact persons responsible for pharmacovigilance and regulatory activities.

The Specialist will also act as local contact person for Pharmacovigilance for the designated country.
Job Responsibilities

Ensure the effective and rapid coordination and management of project deliverables to meet the agreed targets and to comply with the agreed procedures, trackers and templates.

Provide Clients expertise and guidance at national level.
Set-up and coordinate the network of local contact persons (LCPs) for RA and PV in assigned projects

Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.

Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.

Manage LCPs training and assess key performance indicators
Act as main point of contact with the clients for Regulatory and PV Network activities
Act as primary contact person for local regulatory authority / Pharmacovigilance expert in assigned countries
Participate in preparation for audits/inspections and provide department representation for assigned projects as required.
Provide feedback on performance of vendors to aid their assessment.
Review and linguistic input on local Product Information and Mock-ups
Perform local non-indexed literature screening and screening of Regulatory Authority website/s (if applicable for the Client) for potential Adverse Drug Reactions (ADRs) and safety information
Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
Previous experience within the pharmaceutical/CRO industry
Pharmacovigilancetraining and/or working experience and other educational or professional background as required locally
Fluent in English, both written and verbal
Good planning and organizational skills
Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
Why PrimeVigilance

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach.

Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:
Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly, supportive working environment
Opportunity to work with colleagues based all over the world, with English as the company language
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
We look forward to welcoming your application.

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