CEE, Regulatory Affairs Specialist and Pharmacovigilance Officer

About this role

Job Title: CEE, Regulatory Affairs Specialist and Pharmacovigilance Officer
Job Location: Podgorica
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
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.
Essential Functions:
Regulatory Affairs activities:

• Preparation of regulatory applications for obtaining marketing authorizations, variations, notifications, amendments, documentation upgrading and renewal submissions for medicinal products and non-medicinal products, as applicable.

• Preparation of supporting documentation for various types of regulatory applications and requests in purpose of placing the product on the market and/or MA maintenance.

• Preparation of supporting documentation with regards to product recall; communication with contractual partner, CA and other involved parties.

• Assisting contractual partner in regulatory activities with regards to products prices and reimbursement.

• Review of marketing materials with regards to registered product dossier and local legislation.

• Participation in product teams with regards to implementation of regulatory requirements in production.

• Communication and negotiation with CA in relation to relevant RA applications/requests.

• Regular monitoring of relevant local RA legislation and CA web pages and notifying other RA colleagues and contractual partner, as necessary.

• Consultancy and advisory support to contractual partners with regards to locally specific regulatory topics and requirements.

• Developing and maintaining regulatory knowledge on local and EU legislation.

• Preparation of training materials and providing training sessions to RA employees, as well as supervision of training activities of other less experienced RA Department employees.

• Preparation and review of RA Service Agreements.

• Review of Company SOPs and other relevant RA related procedures.

• Participating in RA audits and inspections.

• Maintaining and archiving documentation as per relevant internal Company procedures.

• Can act as Responsible person for documentation in the process of MA obtaining, its variations and renewals appointed on behalf Clinres Farmacija entity, as applicable.

• Other duties as assigned.

Pharmacovigilance activities:

• 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 EU QPPV/EU QPPV deputy in the maintenance of the Pharmacovigilance System Master File (PSMF).

• Cooperation with EU QPPV/EU QPPV deputy in signal management activities.

• Participating in generation/review of Standard Operating Procedures (SOPs) and other relevant procedures related to local and global PV activities and safety monitoring activities for medicinal and non-medicinal products.

• Participating in 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.

• Participating in review of PV Service Agreements (SAs) and Safety Data Exchange Agreements (SDEAs) describing local and global PV activities and safety monitoring activities for medicinal and non-medicinal products.

• Participating in compliance monitoring of ICSR/ safety information reporting, FU, MIE/PQC reporting, PSUR submission, safety variations, literature searches and CAPAs.

• Participating in PV audits and inspections by contractual partners/regulatory authority.

• Developing and maintaining pharmacovigilance knowledge on local and EU legislation.

• Can act as EU QPPV/QPPV deputy or LPVRP/LPVRP deputy for specific client project, or as appointed on behalf of for Clinres Farmacija entity, as applicable.

• Other duties as assigned.

Necessary Skills and Abilities:

• High level of computer literacy.

• Excellent organizational skills with ability to prioritize activities.

•…