Qinecsa Solutions
Website:
qinecsa.com
Job details:
Primary Responsibilities
- Function as primary point of contact for each group of therapeutic areas.
- Lead/Co Lead cross functional teams contributing to periodic safety reports in accordance with Global Pharmacovigilance and Risk Management (GPRM) business rules, standard operating procedures (SOPs), and global regulatory requirements.
- Support roles involved in creation of Aggregate Safety Reports (ASRs) (i.e., PSURs, PADER, DSURs, PBRER’s, Addendum to Clinical Overview’s, Addendum to PSUR’s, Summary Bridging Report’s and RMP Updates), signal validation and evaluation report.
- Review aggregate safety data from the database and generate line listings (LL) and summary tabulations (ST) and include the LL & ST in the appropriate template.
- Creation and review of PSMF, Periodic review of PSMF
- Participate in signal detection and management activities involving detection, validation and evaluation and prioritization.
- Compile the safety data into the relevant sections of periodic reports such as PBRER, PSUR, AdCO, PADER, and DSUR according to the client.
- Reviews and identify the literature that is selected for inclusion in the regulatory document that may lead to the signal detection.
- Ensure that narrative writing/safety report drafting, follow-up activities and all documentation are conducted per client approved project SOP, WI, convention and workflow in collaboration with quality assurance.
- Plan, organize, and manage daily work to meet service level timelines and deliverables.
- Work with the Aggregate Reporting lead to escalate issues or tasks outside the normal scope of work.
- Provide word and PDF versions of the final signed documents to the client.
- Participate in internal and external audits and inspections by clients and health authorities.
- Ensure adequate and appropriate training and training documentation.
- Cross check RMPs as required to draft aggregate reports.
- Ensure appropriate and adequate resource allocation and back-up roles for project continuity and timely delivery.
- Quality delivery through a rigorous metrics-based approach.
- Ensure timeline are being met.
- Perform any other drug safety related activities as assigned.
Secondary Responsibilities
Maintain quality service and departmental standards by:
- Reading, understanding, and adhering to organizational standard operating procedures (SOPs)
- Assisting in establishing and enforcing departmental standards
Contribute to team effort by:
- Working with internal staff to resolve issues
- Exploring new opportunities to add value to organization and departmental processes
- Helping others to achieve results
- Performing other duties as assigned
Maintain technical and industry knowledge by:
- Attending and participating in applicable company-sponsored training
Qualifications
Education: Any Healthcare professional (B Pharm/M Pharm/Pharm D/BDS/Nursing or any other equivalent qualification)
Experience: 5-7 years of experience in Pharmacovigilance / Pharmaceutical / Clinical research
Additional Skills
- Strong motivational skills and abilities, promoting a team-based approach
- Strong interpersonal and communication skills, both verbal and written in English
- Strong organizational and leadership skills
- Goal-oriented
- Ability to maintain professional and positive attitude
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