Pharmacovigilance BU Iberia & Compliance Portugal Officer
Act as local qualifies responsible person for Norgine Pharmacovigilance in Spain and Norgine PV Portugal.
Act as Compliance Officer in Portugal. Oversight of Code of Practice compliance in PortugalSpain, including the management of two global electronic systems: Zinc MAPS and TRACE SharePoint®,
KEY RESPONSIBILITIES & ACCOUNTABILITIES:
Iberia Pharmacovigilance Local Responsible person
- Local Responsible for all Pharmacovigilance activities in Iberia Medical Unit.
- Local Responsible Qualified Person for Pharmacovigilance in Iberia (Spain & Portugal) for Spanish Regulatory Agency (AEMPS) and Portugues Regulatory Authorities (INFARMED).
- Communication of safety related issues including communications from regulators arising local territory level
- Implementation of and compliance with global and local regulatory requirements and Company processes
- Ensure that all AEs promptly and accurately to GPV for processing
- Ensure that relevant local literature not covered by central search for PV is performed by Medical Officer.
- Update the Iberia SOP/WI according to the GPV & Local Regulatory Authorities requirements
- Working with Global Pharmacovigilance to implement training of personnel involved in drug Safety in the Medical Unit
- At least once a year train Iberia Head Office Personnel and Sales Reps on PV and maintain records of the training.
- Ensuring 24h cover in Iberia, for reports of adverse events and special situation reports
- Working with the Qualified person and Global Pharmacovigilance to implement and maintain Safety Data Exchange Agreements. Be updated in the Norgine PV sharepoint information.
- Be responsible of the Local Audits in compliance with Norgine SOP´s and local regulations
- Collects and reports all AEs promptly and accurately to Global Pharmacovigilance for processing.
- Manage Adverse Event reports and follow up in compliance with local regulations and Norgine SOP´s
- Ensuring that a Pharmacovigilance system is implemented and maintained Portugal Compliance OfficerAssists the Iberia Medical Director on duties related to compliance with local Code of Practice requirements. Code of Practice:
- Provision of technical expertise and training with the TRACE SharePoint® tool for Transparency of Transfers of Value
- Maintain oversight of data and timelines for submission of the disclosure
- Support in Methodology Note updating
- Train and support Transparency co-ordinators and Disclosure Approvers
- Manage changes in the system as appropriate
- Prepare KPIs
- Provide Code of Practice and Procedures ITC training to new staff and Code of Practice annual refresher course to all the staff in the Portuguese Affiliate;
- Ensure compliance of Portuguese Business Functions with applicable Codes of Practice including copy approval, transparency of transfers of value:
- Preparation, update and training out of relevant Code related SOP(s) / WI(s)
- Organisation of regular Code specific training for producers, reviewers and signatories
- Oversight of qualification, training and notification of final signatories from PortugalUnit.
- Oversight, tracking, compilation and management of Portugal Code complaints
- Raising queries to APIFARMA Deontological Unit when appropriate
- Conduct horizon scanning with respect to changes in relevant regulations and inform colleagues and departments accordingly;
- Undertake initial review of materials in copy approval;
- 2 - 3 years’ experience in the pharmaceutical industry
- Awareness, understanding and an ability to pragmatically interpret Portuguese Code of Practice requirements relevant to his/her responsibilities
- Knowledge of Pharmacovigilance Spanish & Portuguese Regulations.
- Demonstrates a good ability to analyse data and develop processes
- Focuses on customer needs, follows up on commitments and requests
- Good interpersonal skills
- Excellent verbal and written communication skills
- Works cooperatively within a team
- Delivers goals in a changing environment
- Takes a creative and innovative approach to work
- High level organisation skills with commensurate attention to detail
- Demonstrable analytical and monitoring skills
- Be self-motivated with a proactive nature
- Ability to communicate clearly in Spanish,
- Ability to communicate clearly in Portuguese
- Ability to communicate clearly in English
The fixed salary will depend on the experience of the candidate but our salary policy is to be in the median of the market.
Additionally, the salary package will include a
Bonus according to company policy,
private medical insurance,
Other benefits included are:
good working environment,
being part of a young and dynamic team that has been recognized as a "best mentoring practice" (2017);
associated with the foundation for helping people with disabilities ENVERA (2018);
and adhered to the code "Talent without Gender" of EJE & CON (2019).
Norgine Iberia is proud to have a management team with a 50% distribution between men and women.