PV- ICSR - Senior Executive Job Description Template
The PV- ICSR - Senior Executive will play a crucial role in managing and analyzing individual case safety reports to ensure regulatory compliance. The position involves handling complex data, ensuring quality and accuracy, and collaborating closely with internal teams and external stakeholders.
Responsibilities
- Oversee the processing and evaluation of Individual Case Safety Reports (ICSRs).
- Ensure timely and accurate data entry and coding in safety databases.
- Perform quality control checks to ensure completeness and accuracy of ICSRs.
- Prepare and submit reports to regulatory authorities in compliance with global guidelines.
- Collaborate with cross-functional teams including clinical, regulatory, and medical affairs.
- Participate in signal detection activities and prioritize cases requiring further investigation.
- Provide training and support to junior team members and other relevant staff.
Qualifications
- Bachelor’s degree in life sciences, pharmacy, or a related field.
- Minimum of 3-5 years of experience in pharmacovigilance, particularly in ICSR processing.
- Thorough knowledge of global regulatory requirements and guidelines for pharmacovigilance.
- Excellent written and verbal communication skills.
- Strong analytical and problem-solving abilities.
- Attention to detail and commitment to high quality standards.
- Ability to work independently and as part of a team.
Skills
- Medical coding
- Case processing
- Database management
- Signal detection
- Regulatory compliance
- Analytical skills
- Data entry
Frequently Asked Questions
A PV-ICSR Senior Executive is responsible for managing the collection, processing, and reporting of Individual Case Safety Reports (ICSRs) within pharmacovigilance. They ensure accurate documentation and compliance with international regulations. They also analyze data to identify trends and potential safety concerns regarding pharmaceutical products.
To become a PV-ICSR Senior Executive, candidates typically need a degree in pharmacy or life sciences. Experience in pharmacovigilance is crucial, often starting with an entry-level position and moving into more senior roles as expertise is gained. Continuous learning and certifications in pharmacoepidemiology or drug safety can be beneficial.
The average salary for a PV-ICSR Senior Executive varies based on location, experience, and company size. Generally, the role offers competitive compensation, reflecting the specialized knowledge and responsibilities involved in handling drug safety and compliance within the pharmaceutical industry.
A PV-ICSR Senior Executive typically requires a degree in pharmacy, life sciences, or a related field. Relevant experience in pharmacovigilance or drug safety is essential, along with certifications in safety management. Strong analytical, communication, and regulatory knowledge skills are also vital for success in this role.
A PV-ICSR Senior Executive needs to have strong analytical skills, attention to detail, and excellent communication abilities. Responsibilities include processing ICSRs, preparing reports, ensuring regulatory compliance, and identifying safety trends. Familiarity with adverse drug reaction software and pharmacovigilance databases is also important.