For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Job Summary:
The CEE, Pharmacovigilance Specialist is responsible for performing pharmacovigilance (PV) and safety monitoring activities stipulated by legislation, agreement(s) with contractual partners and internal Company’s procedures related to medicinal and non-medicinal products in countries where ProPharma operates and as delegated by the (deputy) LPPV and/or (deputy) EU QPPV.
Essential Functions:
- Regular monitoring of relevant local and EU PV legislation and Competent Authority (CA) web pages and notifying other PV colleagues and contractual partner if necessary.
- Collecting, seriousness/expectedness assessment, databasing, forwarding to contractual partner, filing, and archiving Individual Case Safety Reports (ICSRs) and/or other safety related information for medicinal and non-medicinal products.
- Follow-up of ICSRs and/or safety related information for medicinal and non-medicinal products with healthcare professionals and consumers and maintaining appropriate records and tracking logs as required.
- Expedited reporting to local CA and Eudravigilance.
- Regular worldwide and local medical and scientific literature screening for ICSRs and relevant safety information identification.
- Monitoring of company sponsored websites and digital/social media.
- Tracking Periodic Safety Update Report (PSUR) submission deadlines and timely submission of PSURs to local CA, where applicable.
- Reconciliation of exchanged safety data with contractual partner’s global PV/safety department.
- Preparation/review of PSUR, Addendum to Clinical Overview (AddCO) and Risk Management Plan (RMP).
- Handling (receipt, responding, tracking, and forwarding to contractual partner if applicable) medical information enquiries.
- Handling of product quality complaints with potential safety impact.
- Maintaining and archiving documentation records of all PV and safety monitoring activities.
- Cooperation with (deputy) EU QPPV in the maintenance of the Pharmacovigilance System Master File (PSMF).
- Cooperation with (deputy) EU QPPV in signal management activities.
- Insertion and maintenance of medicinal products in Extended EudraVigilance Medicinal Product Dictionary (XEVMPD).
- Generation/review of Standard Operating Procedures (SOPs) and other relevant procedures to local and global PV activities and safety monitoring activities for medicinal and non-medicinal products.
- Preparing training materials, providing training to local PV personnel, and filing training records.
- Implementation and forwarding Corrective and Preventive Action (CAPA) reports to contractual partners as required.
- Review of PV Service Agreements (SAs) and Safety Data Exchange Agreements (SDEAs) local and global PV activities and safety monitoring activities for medicinal and non-medicinal products.
- Compliance monitoring of ICSR/ safety information reporting, FU, MIE/PQC reporting, PSUR submission, safety variations, literature searches and CAPAs.
- Providing support to less experienced employees in PV onboarding, training and supervision in performing everyday tasks. Participating in PV audits and inspections by contractual partners/regulatory authority.
- Developing and maintaining pharmacovigilance knowledge on local and EU legislation.
- Can act as (deputy) EU QPPV, (deputy) LPVRP for specific client project, or for ProPharma entity, as applicable.
- Clinical safety reporting to CA and relevant EC, as unblinded part of study team, in a timely manner according to regulatory and sponsor reporting requirements, including but not limited to SUSAR, DSUR, and/or Line Listing reports.
- Other duties as assigned.
Necessary Skills and Abilities:
- Process-orientated with good detail-oriented ability.
- High level of computer literacy.
- Advance English language knowledge (both verbal and written).
- Excellent interpersonal and communication skills.
- Excellent organizational skills with ability to prioritize.
- Knowledge sharing skills.
- Independence in performing tasks and complex projects.
- Multitasking with the ability to successfully manage multiple projects or issues simultaneously.
- Recognizing recurring issues and analyses their causes to reach a solution.
Educational Requirements:
B.Sc./B.A. or higher degree in medicine, pharmacy, dental medicine, medical biochemistry or veterinary medicine.
Experience Requirements:
- At least two years’ experience in the same/similar work in pharmacovigilance field.
- Expertise or access to expertise in relevant areas such as medicine, pharmaceutical sciences, epidemiology and biostatistics. Where the CEE, Pharmacovigilance Specialist has not completed basic medical training, they are assisted by a medically trained person.
- Advanced theoretical and practical knowledge on local legislation necessary for the performance of pharmacovigilance activities.
- Good clinical practice certificate.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
