We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Senior Specialist Pharmacovigilance
Your Job
The position at the Client will consist of the following PV tasks within drug safety:
- Manage the PV relationship and resources within the company and provide pharmacovigilance expertise and support
- Collaborate with Client and key partners to ensure appropriate systems/processes are in place to support the local PV system
- Define and implement the local, regional and global PV strategies together with client
- Manage company PV system to ensure global compliance with commercial team engagements
- Work closely with the internal stakeholders to support and facilitate local PV interactions with sub-functions
- Implement strategies by coordinating with stakeholders to prevent gaps in the assigned territory
- Be the territory SME, covering global, regional, and local regulatory requirements, compliance, and resources
- Establish/support local and/or regional PV suppliers (e.g. local resident QPPV suppliers and PV services)
- Support within assigned cluster in collaboration and agreement with the cluster lead
- Perform local QPPV and/or local PV contact person activities
- Maintain Descriptions of Pharmacovigilance Responsibilities (DPRs) to provide official record of delegation of responsibilities
- Collaborate on PV audits with cluster and compliance leads, including follow-up and CAPA management
- Ensure close collaboration with global Process and Compliance leads in ensuring QA and compliance disciplines, globally, regionally and locally
- Ensure all contact information and any changes of local PV personnel are maintained for GPV communications
After the project has ended the position will consist of tasks within drug safety such as:
- Local and global case management, including follow-up of reports by phone or email
- Translation of case reports from Scandinavian languages (NO, DK and SE) into English, Local (Scandinavian) and global literature screening, as well as create search strings for literature searches
- Register and maintain regulatory information on medicinal products in the Article 57 database/XEVMPD
- Hold local PV roles in one or more Scandinavian countries with responsibility for monthly reports and customer contact
- Coordination of new customer projects for local PV in close collaboration with Nordic and global colleagues
- Follow up on local regulations on pharmaceuticals and pass on relevant information to customers
- Communication with client companies and with regulatory authorities with regard to all pharmacovigilance-focused aspects
- Creation, review, update, and implementation of Pharmacovigilance Agreements (PVAs)
- Preparation and maintenance of Pharmacovigilance System Master Files (PSMFs)
- Assistance/writing of aggregate safety reports (periodic safety update reports, addendum to clinical overview, PADER etc.), development safety update reports, risk management plans and signal detection reports
Your Profile
- Academic bachelor's degree in natural sciences, nursing, pharmacy, or bioengineering
- Advanced experience, with at least 3-5 years in PV related environments
- Meets all applicable local QPPV / PV contact person requirements including education, training, experience
- Excellent knowledge of medical/scientific terminology and PV regulations for the post marketing global environment and applicable legislation
- You should be fluent and have excellent communication skills in Swedish and English orally and in writing, and knowledgeable in other Scandinavian languages
- Well-developed organizational and cross-cultural skills
- Decision making capability and ability to independently resolve problems and conflicts also under pressure
- Service minded and committed to meeting deadlines
- Flexible in terms of work tasks and takes the initiative where needed
- Team player; both asks for and provides support to colleagues when needed
- Used to working independently and taking initiative
- Ability to quickly familiarize yourself with various IT systems
- Work experience within other areas such as quality assurance, regulatory affairs and medical device is an advantage but not a requirement
Diversity and inclusion are an important part of all our work at PharmaLex. We thrive from diversity and welcome applicants of all genders, ages, ethnicities, abilities, beliefs, orientations and backgrounds.
We offer
We offer you an excellent opportunity to develop your knowledge and skills while working on varied and versatile tasks and client assignments. You will be part of a Nordic Pharmacovigilance team and have external business interaction with clients and internal collaboration within the PharmaLex organization and within several areas of the pharmaceutical industry.We have a friendly, social, and open-minded work environment in a global organization. Our office is located in Gothenburg, you are required to go to the office occasionally.
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your CV and application with your salary request through our website as soon as possible. Applications will be reviewed on an ongoing basis so please do not delay applying.
For further information please don’t hesitate to contact us:
Hanne Western
Head of HR Nordics
hanne.western@pharmalex.com or tel. +47 22 23 88 80
