Job Title: Specialist, Pharmacovigilance Epidemiology & Risk Management
Location: Noida, India
About Cencora
Cencora is a leading global pharmaceutical services company dedicated to improving lives through innovative healthcare solutions. We are committed to excellence, integrity, and collaboration in all aspects of our business. As a valued member of our team, you will have the opportunity to contribute to our mission and make a meaningful impact on the healthcare industry.
Job Summary
We are seeking a highly motivated and detail-oriented Specialist in Pharmacovigilance Epidemiology & Risk Management to join our dynamic team in Noida. This role offers a fantastic opportunity for a skilled Pharmacovigilance (PV) professional to utilize their expertise in individual case safety report (ICSR) processing, safety data review, and regulatory reporting within a globally recognized organization. The successful candidate will be responsible for managing end-to-end pharmacovigilance activities, ensuring compliance with global regulations and contributing to the safety of our products.
Responsibilities
As a Specialist, Pharmacovigilance Epidemiology & Risk Management, you will be responsible for the following:
-
ICSR Processing & Safety Review:
- Perform triage and validity assessment of various case types, including spontaneous reports, health authority reports, clinical trial reports, and literature cases.
- Accurately enter case details into the PV safety database.
- Conduct thorough Initial Case Safety Report (ICSR) assessments to identify potential safety signals.
-
Regulatory Reporting & Documentation:
- Evaluate expedited reporting requirements to global Health Authorities, adhering to strict timelines and regulations.
- Prepare and submit regulatory reports, including CIOMS I forms, MedWatch forms, and XML reports.
- Generate and send follow-up requests to obtain additional information related to safety cases.
- Submit ICSRs to relevant partners and regulatory agencies, ensuring accurate and timely submissions.
-
Quality Assurance:
- Ensure complete and accurate documentation of all pharmacovigilance activities, adhering to company standard operating procedures (SOPs) and regulatory guidelines.
- Conduct quality checks on ICSRs and other PV documents to maintain compliance with industry standards and internal policies.
- Retrieve ICSRs from the EVWEB database and perform company/non-company case assessments as required.
-
Team Support:
- Mentor and guide new team members, providing training and support to ensure their successful integration into the department.
- Assist supervisors in executing process-specific tasks, contributing to the overall efficiency and effectiveness of the PV team.
Qualifications & Skills
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field.
- Proven experience in ICSR processing, PV operations, and safety reporting within a pharmaceutical or biotechnology company.
- A strong understanding of global pharmacovigilance guidelines and regulations, including those from the FDA, EMA, and other international health authorities.
- Proficiency in safety databases, such as Argus or ARISg, and regulatory reporting tools.
- Excellent communication skills, both written and verbal, with the ability to effectively communicate complex safety information to various stakeholders.
- Strong attention to detail and the ability to work independently and as part of a team.
- Demonstrated ability to manage multiple tasks and prioritize workload to meet deadlines.
Benefits at Cencora
- Full-time, permanent employment with a stable and growing global organization.
- Competitive salary package commensurate with industry standards and experience.
- Opportunities for professional growth and development within a globally recognized pharmaceutical services company.
- A supportive and inclusive work environment that values diversity and promotes equal opportunities for all employees.
- Accommodation for disabilities as per legal requirements, ensuring a fair and accessible workplace.
Join Cencora
If you are a dedicated and experienced Pharmacovigilance professional seeking a challenging and rewarding opportunity, we encourage you to apply. Join our team at Cencora and contribute to our mission of improving lives through innovative healthcare solutions. We look forward to receiving your application!