[Job Description]
1. Management of Individual Case Safety Report (ICSR) from all relevant sources
- Report incoming adverse events, Mis, and PQCs to PV CRO and Site Quality/QA Department (complaints) as applicable.
- Ensures a local tracking system is in place, to ensure timely submissions of adverse events to PVO/ PV CRO and of ICSRs and Periodic Reports to the Regulatory Authority.
- Completes monthly ICSR reconciliation with interacting departments and/or partner companies (if applicable) and acts upon any discrepancies.
- Ensures that local processes, procedures and systems are in place for recording, processing, conducting follow up and translating adverse events and other safety information reportable to PVO/ PV CRO
2. Oversight of PV Medical Compliance Risk Management Plan Implementation
- Contributes to the development of local RMP and ensures oversight of its implementation in collaboration with relevant staff in accordance with Lotus policies and procedures, global and local regulatory requirements.
3. Safety Communications
- Acts as a point of contact for local Health Authorities and ensures communication of relevant safety information to external key stakeholders as required
- Acts as the key Affiliate contact for internal audits
4. Management of Aggregate Reports
- Provides Safety-related information to PVO and PV CRO for the preparation of Aggregate Reports as required
- Maintains oversight of submission of PSURs/PBRERs to local regulatory authorities in accordance with Lotus policies and procedures and local regulatory requirements.
5. PV Quality
- Ensures local processes and procedures are in place to clearly define pharmacovigilance responsibilities within the Affiliate in line with Global SOPs and local regulations.
- Review give input during development of Lotus pharmacovigilance SOPs.
6. Contract Review and PV Agreements
- Reviews contracts and provides input on necessary clauses/sections/ wording for ensuring PV medical compliance
- Reviews and approves the safety clauses/sections/wording in local commercial agreements
- Ensures preparation and execution of PV agreements, as required
- Maintains oversight of PV activities as outlined in PVA
[Requirements]
1. Bachelor’s degree above (Major: Pharmacy, Nursing, Life Science, etc.) preferred
2. Medical/Pharmacovigilance area in Pharmaceutical company or Hospital or Pharmacy preferred
3. 2 or more years of bio-pharmaceutical and/or clinical experience is preferred
4. Technical skills
- Knowledge and expertise in drug development; Product and disease knowledge; Use of regulations, policies and procedures
- Clear understanding of company policy and the role of pharmacovigilance in business
5. Managerial skills
- Strategic focus, Problem-solving, Interpersonal effectiveness, Leading & developing people
6. Required English Proficiency above Working Confident
[Job Description]
1. Management of Individual Case Safety Report (ICSR) from all relevant sources
- Report incoming adverse events, Mis, and PQCs to PV CRO and Site Quality/QA Department (complaints) as applicable.
- Ensures a local tracking system is in place, to ensure timely submissions of adverse events to PVO/ PV CRO and of ICSRs and Periodic Reports to the Regulatory Authority.
- Completes monthly ICSR reconciliation with interacting departments and/or partner companies (if applicable) and acts upon any discrepancies.
- Ensures that local processes, procedures and systems are in place for recording, processing, conducting follow up and translating adverse events and other safety information reportable to PVO/ PV CRO
2. Oversight of PV Medical Compliance Risk Management Plan Implementation
- Contributes to the development of local RMP and ensures oversight of its implementation in collaboration with relevant staff in accordance with Lotus policies and procedures, global and local regulatory requirements.
3. Safety Communications
- Acts as a point of contact for local Health Authorities and ensures communication of relevant safety information to external key stakeholders as required
- Acts as the key Affiliate contact for internal audits
4. Management of Aggregate Reports
- Provides Safety-related information to PVO and PV CRO for the preparation of Aggregate Reports as required
- Maintains oversight of submission of PSURs/PBRERs to local regulatory authorities in accordance with Lotus policies and procedures and local regulatory requirements.
5. PV Quality
- Ensures local processes and procedures are in place to clearly define pharmacovigilance responsibilities within the Affiliate in line with Global SOPs and local regulations.
- Review give input during development of Lotus pharmacovigilance SOPs.
6. Contract Review and PV Agreements
- Reviews contracts and provides input on necessary clauses/sections/ wording for ensuring PV medical compliance
- Reviews and approves the safety clauses/sections/wording in local commercial agreements
- Ensures preparation and execution of PV agreements, as required
- Maintains oversight of PV activities as outlined in PVA
[Requirements]
1. Bachelor’s degree above (Major: Pharmacy, Nursing, Life Science, etc.) preferred
2. Medical/Pharmacovigilance area in Pharmaceutical company or Hospital or Pharmacy preferred
3. 2 or more years of bio-pharmaceutical and/or clinical experience is preferred
4. Technical skills
- Knowledge and expertise in drug development; Product and disease knowledge; Use of regulations, policies and procedures
- Clear understanding of company policy and the role of pharmacovigilance in business
5. Managerial skills
- Strategic focus, Problem-solving, Interpersonal effectiveness, Leading & developing people
6. Required English Proficiency above Working Confident