Senior Specialist, Regulatory and Pharmacovigilance

Ergomed; Barcelona; A distancia; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical industry is seeking a Senior Specialist Regulatory and PV Network to lead regulatory strategy and pharmacovigilance efforts. This role requires strong leadership skills and experience within the pharmaceutical sector. The ideal candidate will ensure compliance with regulatory requirements and foster collaboration across various teams while providing leadership on complex projects. If you are passionate about regulatory affairs and want to work in a diverse environment, this position could be perfect for you.

Servicios

Training and career development opportunities

Supportive working environment

Opportunity to work with an international team

Formación

• Experience within pharmaceutical or CRO industry or Regulatory body is essential.
• Fluency in English and proficiency in the official language of the country are necessary.
• Good organization and planning skills are highly valued.

Responsabilidades

• Act as Local Contact Person for Pharmacovigilance.
• Manage and ensure delivery of regulatory projects.
• Foster professional relationships with internal and external contacts.

Conocimientos

Interpersonal skills

Organizational skills

Problem-solving

Knowledge of ICH GCP

Educación

Bachelors Degree in Chemistry or Life Sciences

Descripción del empleo

The Senior Specialist Regulatory and PV Network is responsible for developing the strategy based on regulatory requirements and for driving 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 Senior Specialist will also act as Local Contact Person for Pharmacovigilance for the designated country.

Job Responsibilities

• Act as Local Contact Person for Pharmacovigilance for the designated country
• Assume leadership and functional representation for projects of medium / high complexity ensuring effective and rapid coordination and management of regulatory deliverables driving the team to meet the agreed targets and to comply with the agreed procedures trackers and templates
• With the help of a senior member of the team develop strategy and manage set up activities (Project Management Plan joint operating procedures POAs and core documents)
• Provide strategic input to internal and external customers and promptly identify and address any risk / potential risk by implementing preventive measures
• Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures
• Collect review track and maintain LCPs CVs job descriptions training records contact details and monthly reports
• Ensure correct training assignment to and training compliance by the LCPs
• Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated monitor project budgets hours spent vs budgeted and promptly identify and escalate any OoS
• Provide support to proposal development and input to budgets provide department representation to BD meetings as required
• Prepare clients invoices and review / approve vendors project invoices
• Provide training coaching and mentoring to junior members of staff
• 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
• Participate in and / or support junior members in preparation for audits / inspections and provide department representation for assigned projects as required
• Track LCPs key performance indicators and prepare monthly summary reports
• Provide feedback on performance of vendors to aid their assessment
• Provide input to department / company initiatives and contribute to the design / review of SOPs / working practice / guidance.

Qualifications :

• Bachelors Degree in Chemistry or Life Sciences Nursing or equivalent experience
• Strong experience within pharmaceutical or CRO industry or Regulatory body
• Good knowledge of ICH GCP and / or GVP and national regulations for territories of competency
• PV training and / or working experience and other educational or professional background as required locally
• Fluent in English both written and verbal
• Candidatemust be proficient in the official language of the country in which they are based as this is essential for local interactions and compliance
• Proficiency in German French or Italian is a plus but not mandatory
• Good planning and organizational skills
• Strong interpersonal skills in a fast-paced deadline oriented and changing environment

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

We look forward to welcoming your application.

LI remote

Remote Work : Employment Type :

Full-time

Key Skills

Experience : years

Vacancy : 1