Reports To: Head Safety Operations APAC
Scientific/Pharmacy/RN/MD degree or equivalent
Provide PV services to local affiliate in fulfillment of SDEA with partner including local adverse event collection and follow up as needed, recxonciliation with partner database and support of other post-approval PV commitments.
Essential Functions of the job:
Case Management and Processing
- Triaging of ICSRs to sustain regulatory expedited reporting compliance
- ICSR Management:
- Post Marketing ICSR Management
- Post-marketing case receipt, pre-triage, follow-up, distribution & submission
- Translations for each activity
- Post Marketing ICSR Management
- Reconciliations from multiple sources external and internal
- Support Celgene DSRM Manager in the local implementation and maintenance of local RMin Programmes (as per the product Risk Management Plan).
- Support the Celgene DSRM Manager in Risk Minimisation in Affiliate led Organised Data Collection Schemes to support GDSRM’s oversight, including but not limited to:
- Risk Minimisation Programme compliance and effectiveness measures, when applicable
- Other projects, such as PASS and PAES where applicable e.g. provision of Additional Educational Materials for Risk Minimisation.
- Pre-approval Access e.g. implementation and maintenance of applicable Risk Minimisation Programmes
- Translations, if applicable
Management and oversight of locally led data collection activities:
- Support Celgene DSRM Manager in Affiliate led Organised Data Collection Schemes to support GDSRM’s oversight, including but not limited to:
- Non-interventional studies
- Patient Support Programs
- Market Research Surveys (review of surveys/questionnaires and protocols, contracts and vendor training)
- Other projects such as PASS and PAES where applicable
- Pre-approval access (e.g. Compassionate Use, Named Patient Programs)
- Interventional & non-interventional IIT protocols, CRFs, ICFs and contracts review
- IITs Sponsors/CROs training
- Support DSRM Manager, to Provide PV input/safety reporting training to Investigator Meetings including IITs and Celgene Sponsored
- Support the reconciliation of DSURs/ASRs (periodic aggregate reports)
PV Compliance and Quality:
- Support Celgene DSRM Manager in oversight of Affiliate and Partner adherence to Compliance and Quality Standards as defined by GDSRM.
- Support the Implementation and comply with relevant policies and procedures.
- Compliance with regulatory PV requirements and with Celgene’s requirements.
- Support continuous Inspection and Audit readiness and support successful and timely responses to CAPAs.
- Issue management: timely escalation of potential compliance issues
- Support the DSRM Manager in ensuring Third Party Vendors conducting activities of the
Regulatory Authority Interactions:
- Escalation to Celgene of enquiries from regulatory agencies and Healthcare Professionals on safety and Risk Minimization questions for marketed products
- Support Celgene DSRM Manager to provide Local Drug Safety input into DHPC Letters
- Support Celgene DSRM Manager in notification process for Additional Educational Materials per the product Risk Management Plan (where applicable)
Routine Pharmacovigilance Activities:
- Report any potential safety issue in a timely, open and appropriate manner to the whom it may concern (i.e. Drug Safety Manager/Drug Safety Ass Dir, Medical Director, etc.)
- Collaborate in providing Adverse Event and Risk Minimisation Programme Training to local staff/third parties
- Participate in Product Quality Complaint interactions or process PQCs (where applicable)
- Participate in Medical information interactions or process safety related inquiries
- Contribute to the local literature review (where applicable)
- Contribute to local legislation review and local gap analysis (where applicable)
- AE Reconciliation with stakeholders
- Collaborate in local SOPs & WPs development & maintenance
- Local Drug Safety email box daily monitoring and management
- Ensure Business continuity
- Act as back-up to DSRM Manager if required
- Maintain awareness of local Pharmacovigilance regulations
Continuous Process Improvement:
- conduct of local Quality and Compliance initiatives
Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management – Communicates changes and progress; Completes projects on time and budget.
Computer Skills : Functional knowledge of Microsoft Office software
Other Qualifications : 3-5 years Pharmacovigilance experience preferably in a multinational company