Pharmacovigilance & Medical Information Executive
Pharmacovigilance & Medical Information Executive
CNX Therapeutics
Job description
Want to make career in medical information & medication safety? Check out EPharmacovigilance & Medical Information Executive job opening at CNX Therapeutics.
Company Description
CNX Therapeutics is a specialized pharmaceutical firm based in Europe that provides vital drugs for neurological illnesses, critical care and other medical requirements. It has a presence in more than 60 countries through direct distribution and strategic alliances, with an emphasis on enhancing patient access to therapies. The company is also a B Corporation Certified.
Job Summary
The Pharmacovigilance Associate is a complete remote employment role based in Quality department in Mumbai, India. The case processing associate supports drug safety operations, compliance, quality management and medical information services. The PV executive will liaise with the Senior Manager and external service providers to ensure that adverse events are processed and reported appropriately, medical inquiries are responded to accurately and paperwork is complete and available for audit or inspection.
Key Responsibilities
Support day-to-day pharmacovigilance activities in compliance with applicable regulations, organizational processes and industry norms.
Ensure the completeness, accuracy and maintenance of safety records and pharmacovigilance paperwork in an inspection ready condition.
Monitor the pharmacovigilance email inboxes and escalate safety information for processing accordingly.
Support the reconciliation of safety data between internal departments and external business partners.
Engage in due diligence operations for potential mergers and acquisitions and integration of acquired firms.
Support the examination and upkeep of the Pharmacovigilance System Master File (PSMF).
Adhere to appropriate Good Pharmacovigilance Practices (GVP), regulatory regulations, company policies, and quality standards.
Help ensure compliance with standard operating procedures, work instructions, forms and regulated documents.
Perform Corrective and Preventive Action (CAPA) activities, deviation management and change control activities.
Support pharmacovigilance agreements and monitor compliance of external vendors and partners.
Support with internal audits, partner audits, regulatory inspections and compilation of supporting paperwork.
Educational Qualification
A Bachelor's degree in a healthcare-related or life sciences discipline.
Proven experience working with pharmacovigilance and medical information providers or external partners.
Knowledge of European Union (EU) and United Kingdom (UK) Good Pharmacovigilance Practices (GVP).
Knowledge of ICH requirements and how to apply them to pharmacovigilance and medical information operations.
Skills Required
Knowledge of drug safety reporting and pharmacovigilance activities.
Knowledge of EU and UK GVP regulations and applicable ICH guidelines.
Ability to oversee external suppliers providing safety data processing and medical information services.
Strong documentation and record-keeping skills.
Ability to monitor safety information and escalate in a timely manner.
Knowledge of evidence-based medical information management and scientific communication.
Excellent communication abilities (written and verbal).
Interact well with internal teams, vendors and business partners.
Knowledge in quality management, CAPA, deviation reporting and change control.
Knowledge of audit and regulatory inspection requirements.
Being proactive on quality compliance and process improvement.
Ability to function as a member of a team and prioritize patient safety.
Salary Structure
The average yearly compensation of a Pharmacovigilance Executive might range from around ₹7 Lakhs - ₹8 Lakhs per annum.
Career Development
This role, as a drug safety associate, provides experience in global drug safety, medical information, vendor oversight and regulatory compliance. This can lead to further progression into senior posts in pharmacovigilance, medical information management, quality assurance or drug safety compliance.
How to Apply
Go to our job portal and search for Pharmacovigilance & Medical Information Executive opening.
Click on the listing to get the complete job description, qualifications and standard remote employment conditions.
Fill in the details and upload your resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
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Hiring Trends
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