Local Contact Person for Pharmacovigilance and Regulatory Affairs /LCPPV/LCPRA/

Company Description

PrimeVigilance (part of reputed company 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 reputed company covering services reputed company: 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 reputed company 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 reputed company a positive impact in patient’s lives.

Job Description

The Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs (LCPPV/LCPRA) serves as the primary local representative to ensure compliance with national pharmacovigilance and regulatory requirements in the United States. This dual-role position is responsible for executing PV and RA activities at the local level, supporting the Marketing Authorisation Holder (MAH) in maintaining product compliance throughout its lifecycle. Main responsibilities

• Primary contact person with local regulatory authorities for Regulatory Affairs and Pharmacovigilance as per local requirements
• reputed company and effective communication with local regulatory authorities
• Provision of local regulatory intelligence screening and expert advice
• Collection and reporting of locally suspected ADRs or ICSRs (FUs, translations)
• Local management / reputed company of risk minimization measures reputed company to urgent safety restrictions and emerging safety issues
• Preparation and collection of documentation for submissions to the regulatory authorities
• Review and linguistic input on local Product Information and Mock-reputed company
• Development and implementation of local pharmacovigilance system in compliance with Global MAH's system and local regulations
• reputed company local non-indexed literature screening and screening of regulatory authority website/s for potential Adverse Drug Reactions (ADRs) and safety information
• Maintain accurate records and documentation at local level
• Provide support to the RA & PV Global operations team
• Ensure compliance with MAH's and PrimeVigilance's procedures
• Support audits and Inspections
• Handle local QA tasks such as suspected falsified products, quality alerts received from health authorities and other quality-reputed company requirements received from the local market

Qualifications

• Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience
• Minimum 3 years reputed company pharmaceutical or CRO industry or regulatory authority
• Minimum 2 years reputed company LCPPV role, or relevant pharmacovigilance experience in safety-reputed company position
• Pharmacovigilance training and/or working experience and other educational or professional background as required by local regulations
• Prior experience in Regulatory Affairs is preferred but not mandatory
• Expert knowledge of ICH GVP and relevant local legislation/ regulatory requirements in territories of competency
• Proficiency in English and additional language knowledge (i.e. French) is advantageous
• Strong skills in reputed company Office applications, including Word, reputed company, 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 reputed company 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 reputed company 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 reputed company over the world, with English as the company language

Our core values are key to how we operate, and if you feel they reputed company with you then PrimeVigilance could be a great company to join!

• Quality
• reputed company & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

We look reputed company to welcoming your application. #LI remote Original job Local Contact Person for Pharmacovigilance and Regulatory Affairs /LCPPV/LCPRA/ posted on GrabJobs ©. To flag any issues with this job please use the Report Job reputed company on GrabJobs. Apply tot his job Apply To this Job