Manager, Drug Safety Physician, Pharmacovigilance, Epidemiology – Risk Management
Recruiting.com
full-time
Posted on:
Location Type: Office
Location: Hyderabad • 🇮🇳 India
Visit company websiteJob Level
SeniorLead
About the role
- Conduct initial assessment and Medical Review of ICSR’s into the safety database.
- Review and verify appropriate selection of adverse events from source documents.
- Check the seriousness criteria, appropriate MedDRA code, suspect drug, concomitant medications, lab data, medical history, labelling, causality.
- Review narrative and provide Company Causality Comment.
- Review and respond to any queries/comments from the Case Owner in the Safety database.
- Escalate complex case issues on client products to Team Lead/Line Manager.
- Provide documentation of the review and case comments in Safety database in Medical Review workflow.
- Train and mentor PV associates on event capturing and general PV conventions as required.
- Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas.
Requirements
- Degree in Medicine
- PG degree in any discipline is an advantage but not mandatory.
- Minimum 8 years of relevant experience in Pharmacovigilance & Drug Safety.
- Strong interpersonal and organizational skills to be a good team player.
- High sense of responsibility, dedication, and desire to work under pressure as required.
- Highly service oriented.
- Previous exposure to corporate environment, pharma and life sciences industry is an advantage.
- Good communication skills.
- Fluent in English- spoken and written.
Benefits
- Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Medical ReviewICSR assessmentadverse event selectionMedDRA codingcausality assessmentevent capturingPharmacovigilanceDrug Safetydocumentationsafety database management
Soft skills
interpersonal skillsorganizational skillsteam playerresponsibilitydedicationability to work under pressureservice orientationcommunication skills
Certifications
Degree in MedicinePG degree in any discipline