Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV / LCPRA) - English & Spanish (French is also preferred) Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV / LCPRA) - English & Spanish (French is also preferred)
3 days ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
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.
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
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. 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
* Prompt 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 / oversight of risk minimization measures related 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-ups
* Development and implementation of local pharmacovigilance system in compliance with Global MAH's system and local regulations
* Perform 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-related requirements received from the local market
Qualifications
* Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience
* Minimum 3 years within pharmaceutical or CRO industry or regulatory authority
* Minimum 2 years within LCPPV role, or relevant pharmacovigilance experience in safety-related 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 Spanish, both written and verbal. French language skills are also preferred.
* Strong skills in Microsoft Office applications, including 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
We look forward to welcoming your application.
remote Seniority level
* Seniority level Mid-Senior level
Employment type
* Employment type Full-time
Job function
* Job function Management and Manufacturing
* Industries Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at PrimeVigilance by 2x
Get notified about new Drug Safety Specialist jobs in Madrid, Community of Madrid, Spain .
Senior Clinical Research Associate - CNS / Oncology - Spain - Remote
Madrid, Community of Madrid, Spain 2 weeks ago
Madrid, Community of Madrid, Spain 4 days ago
Quality Specialist (Pharmacovigilance and Drug Safety)
Madrid, Community of Madrid, Spain 2 weeks ago
Clinical Research Associate II / Sr. CRA, Spain
Madrid, Community of Madrid, Spain 2 weeks ago
Madrid, Community of Madrid, Spain €30,000.00-€70,000.00 2 days ago
Madrid, Community of Madrid, Spain 1 week ago
Madrid, Community of Madrid, Spain 2 months ago
Madrid, Community of Madrid, Spain 3 weeks ago
Clinical Research Associate 2 - CFSP & Multisponsor
Madrid, Community of Madrid, Spain 3 weeks ago
Madrid, Community of Madrid, Spain 1 day ago
Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV / LCPRA) - English & Spanish
Madrid, Community of Madrid, Spain 3 days ago
Experienced Clinical Research Associate - Multisponsor (Sevilla)
Madrid, Community of Madrid, Spain 3 days ago
Senior Feasibility Associate / Feasibility Manager Pharmacovigilance Safety Writer (Fixed Term Contract)
Madrid, Community of Madrid, Spain 1 day ago
Madrid, Community of Madrid, Spain 2 weeks ago
Senior Feasibility Associate / Feasibility Manager Qualified Person Responsible for Pharmacovigilance (QPPV) in the EU and UK (homebased)
Madrid, Community of Madrid, Spain 3 days ago
In-house Clinical Research Associate II (Italian speaking) - Europe - Remote
Madrid, Community of Madrid, Spain 2 weeks ago
Senior Specialist, Regulatory & Pharmacovigilance
Madrid, Community of Madrid, Spain 3 days ago
Madrid, Community of Madrid, Spain 3 days ago
Senior Clinical Research Associate - CFSP
Madrid, Community of Madrid, Spain 3 weeks ago
Madrid, Community of Madrid, Spain 1 day ago
Greater Madrid Metropolitan Area 3 days ago
Experienced Clinical Research Associate (sign on bonus)
Madrid, Community of Madrid, Spain 2 weeks ago
Madrid, Community of Madrid, Spain 2 days ago
Madrid, Community of Madrid, Spain 2 days ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
J-18808-Ljbffr
#J-18808-Ljbffr