Specialist, Regulatory and PV Network Lisboa

Specialist, Regulatory and PV Network
Lisboa
Lisboa, Lisboa, Portugal

Company Description

Prime
Vigilance (part of Ergomed Group) is a specialised
- 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 covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

Prime
Vigilance provides
- class support to our pharmaceutical and biotechnology partners, maintaining
- lasting relationships and becoming one of the global leaders in its field. We cover all therapy areas, including medical devices.

We invest in our staff by providing an excellent training and development platform. We value employee experience,
- being, and mental health, acknowledging that a healthy
- life balance is critical for employee satisfaction and nurtures an environment for
- quality client service.

Come and join us in this exciting journey to make a positive impact in patients’ lives.

Job Description

The Specialist, Regulatory and PV Network is responsible for providing the strategy based on regulatory requirements and for completing regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities, and/or consultants in the planning, organizing, and preparing of regulatory deliverables following project, corporate, and industry regulatory strategies.

The Specialist will also act as Local Contact Person for the designated country.

Job Responsibilities

1. Under the direction of a senior member of the team, assume leadership and functional representation for projects of low complexity assigned, ensuring effective coordination and management of deliverables to meet agreed targets and comply with procedures.
2. Provide intelligence on requirements and contribute to the development of the strategy and set up activities (Project Management Plan, joint operating procedures, POAs, and core documents). Support identification of issues and corrective actions.
3. Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details, and monthly reports.
4. Ensure correct training assignment to and training compliance by the LCPs.
5. Promptly identify and escalate risk/potential risk to the project team which may jeopardize deliverables.
6. Provide clients expertise and guidance at the national level.
7. Maintain awareness of allocated tasks and hours and promptly identify and escalate any Oo
   S.
8. Prepare client invoices and review/approve vendors’ project invoices.
9. Provide support to proposal development and input to budgets, and provide department representation to BD meetings as required.
10. Foster professional working relationships with internal and external contacts at local and international levels to ensure smooth and efficient service delivery.
11. Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.
12. Participate in preparation for audits/inspections and provide department representation for assigned projects as required.
13. Track LCPs' key performance indicators and prepare monthly summary reports.
14. Provide feedback on performance of vendors to aid their assessment.
15. Communicate suggestions for changes to departmental/company processes/procedures.

Qualifications

1. Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
2. Previous experience within the pharmaceutical/CRO industry
3. PV training and/or working experience and other educational or professional background as required locally
4. Fluent in English, both written and verbal
5. Candidate must be proficient in the official language of the country in which they are based, as this is essential for local interactions and compliance.
6. Good planning and organizational skills
7. Strong interpersonal skills in a
   - paced,
   - oriented, and changing environment
8. Good attention to detail

Additional Information

Why Prime
Vigilance

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

To succeed, we must work together with a
- first approach. Our people are our greatest strength, leading to our continued success in 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 Prime
Vigilance could be a great company to join!

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

We look forward to welcoming your application.

Seniority Level

Entry level

Employment Type

Full-time

Job Function

Legal