Turkey Job Openings
Excelya
Drug Safety Officer
FULL TIME
October 7, 2024
- Take over Local Safety Officer role (or deputy Local Safety Officer role) for Clients.
- Participate in web calls/teleconferences/meetings/audits/inspections.
- Operate 24/7 safety phone line.
- Handle case reports, complaints, queries and requests.
- Operate electronic systems and databases for case processing, coding, safety reporting to the relevant authorities and product/company/individual/document registration.
- Report timely to the authorities, as applicable.
- Maintain tracking systems (e.g. adverse event/query/complaints lists, journal lists, product lists, project lists, submission lists etc.).
- Monitor changes in local or non-local vigilance related legislation (including guidelines, circulars, directives, initiatives etc.) and notify timely external/internal stakeholders.
- Update/review quality management system documents.
- Perform filing/storage/tracking.
- Perform internal/external reconciliation as applicable.
- Submit or assist for submission of vigilance related documents and reports.
- Handle communication with external stakeholders (Clients, regulators, local collaborators etc.).
- Perform review/quality control to vigilance related documents.
- Organize and conduct trainings.
- Provide input to safety data exchange agreements.
- Perform translations or quality control on translations.
- Perform literature search.
- Prepare aggregate safety reports.
- Prepare Risk Management Plans (RMPs)/Trend reports, assist in or handle communication of new safety information, ensure local RMP implementation, perform risk management/minimization activities and monitor compliance/effectiveness of the activities, for products of PV&SD Clients.
- Perform risk-benefit assessment/signaling.
- Prepare and maintain the PV System Master File/Safety Management Plan.
- Monitor generic mailbox(es).
- Monitor compliance/Key Performance Indicators (KPIs), keep compliance metrics, KPIs metrics.
- Handle or assist in handling PV & Safety promotional activities.
- Prepare quality management system documents (e.g. standard operating procedures, instructions).
- At least 2 years in a PV role.
- Medical Doctor or Pharmacist or Licensed Healthcare professional.
- MS Outlook, Word, Excel, Power Point literate.
- Sense of responsibility and confidentiality.
- Ability in handling documents/trackers.
- Attention to detail, ability to multi-task, team player, self-motivated and able to work both independently and within teams.
- Ability to perform as trainer.
- Very good organization, communication skills.
- Goal/result oriented and problem-solving personality.
- Adaptative, time management skills, presentation skills.
- Ability to work with little or no supervision.
- Prioritizes effectively, acts proactively and client focused.
- Fluency in English.
Summary
-
Type of job:
Full-time -
Location:
Turkey -
Capability:
Pharmacovigilance & Safety
Contact
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