Regulatory Affairs Specialist

3 mesi fa

Roma, Italia PrimeVigilance A tempo pieno

Company Description

We are PrimeVigilance (part of Ergomed PLC), 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.

**Job Description**:
The Specialist, Regulatory and PV network will assume leadership and functional representation for projects assigned and coordinate the local contact persons responsible for regulatory and pharmacovigilance activities.

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

**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
- Managing project budget including vendor costs
- 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

**Qualifications**:

- Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
- Previous experience within the pharmaceutical/CRO industry
- PV training and/or working experience and other educational or professional background as required locally
- Fluent in English and German, both written and verbal
- Good planning and organizational skills
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Good attention to detail

Additional Information
**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
- Collaborative Partnerships

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