Drug Safety Officer - Turkey

Responsibilities:

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).

female-manager-stands-addressing-team-at-board-meeting-picture-id904596172

Minimum Requirements :

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.