Regulatory and Pharmacovigilance Manager.

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Company Description

PrimeVigilance (part of Ergomed Group), is 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

Job Description

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

Job Responsibilities

• Assume leadership and functional representation for projects and/or deliverables of medium/high complexity ensuring effective and rapid coordination and management and execution of regulatory tasks, driving the team to meet the agreed targets and to comply with the agreed procedures.
• Develop strategy and manage set up activities (Project Management Plan, joint operating procedures and core documents) ensuring compliance and consistency with department standards. Support team members in preparing project strategy.
• Act as Local Contact Person for the designated country
• Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures. Problem solve and ensure satisfactory resolution of performance issues or delivery failures.
• Provide expert advice to Clients addressing complex queries and changes in local regulations/guidance.
• Set-up and coordinate the network of local contact persons(LCPs) for RA and PV in assigned projects.
• Ensure correct training assignment to and training compliance by the LCPs.
• Prepare client's invoices and review/approve vendor's 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.
• Prepare and/or contribute to the Regulatory Newsletter and update regulatory database when new information is available.
• Ensure collection, QC review and timely dissemination of all regulatory intelligence related to departmental deliverables. Support interpretation and impact analysis on legislation.
• Support client qualification activities. Ensure audit readiness and assign team members to participate as departmental representatives for audits/inspections and provide responses to any findings/follow up questions.
• Contribute to the assessment and qualification of new vendors and ensure appropriate training and compliance with company standards. Support ongoing evaluation of existing vendors.
• Assist in securing new business or repeated business by participating to BDMs, developing and reviewing regulatory sections of proposals, regulatory costing and budgets.
• Drive department / company initiatives, act as a change champion and successfully manage implementation of the changes (communication, timing and implementation plan).

Qualifications

• University degree in Biomedical sciences, Natural sciences or Health Sciences is required: Nursing, Pharmacy or BS/Master degree in a scientific discipline; or equivalent advanced degree with experience; or relevant previous PV experience
• Strong experience within pharmaceutical or CRO industry or Regulatory body, with demonstrated experience in a leading/project management role
• Proven ability to successfully manage global projects
• Excellent organizational and management skills are essential attributes
• Strong planning, strategizing, managing, monitoring, scheduling, problem-solving and critiquing skills
• Exceptional written and verbal communication skills to clearly and concisely present information
• Outstanding interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Remarkable attention to detail
• Excellent ability to manage multiple tasks, set priorities, and adapt to changing work assignments
• Ability to exercise sound judgment and make decisions independently
• Proficiency in English, both written and verbal
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint

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

We look forward to welcoming your application.

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