As a Senior Medical Safety Physician
- Conduct review and assessment of individual case safety reports obtained from clinical trials, spontaneous and solicited reports
- Determine regulatory reportability of cases obtained from clinical trials, spontaneous and solicited reports within assigned therapeutic team and across all products/sites, as necessary, and in a timely fashion
- Perform triage of cases and determine seriousness and relatedness across products as assigned
- Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labeling, review narrative.
- Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas
- Escalate complex case issues on client product(s) to the medical review team of the client as appropriate
- Conduct assessment of litigation cases across products as assigned
- Identify and resolve case issues, coordinate with client therapeutic teams/site for specific products or functional groups
- Communicate and interact effectively within and across all client therapeutic teams, and within functional team management as appropriate
- Acquire and maintain knowledge of applicable Global Health Authority regulations
- Perform any other drug safety related activities as assigned
Specialized knowledge and skills:
- Experience with relevant safety databases and related software applications
- Proven experience in customer handling and relationship.
- Proven ability to perform task management.
- Proven people management skills.
- Must have good presentation skills and the ability to give presentations.
- Knowledge of the Life Sciences Industry and life cycle of drug.
- Relevant product and industry knowledge
- strong competence with medical and therapeutic terminology
- Understanding of Patient Safety regulatory obligation
- Good attention to detail
- Ability to deliver within established timelines
- Fluency in Spoken and written English and excellent comprehension
Education: MBBS / MD
Experience: 2-4 years of experience in pharmacovigilance
- Strong motivational skills and abilities, promoting a team-based approach
- Strong interpersonal and communication skills, both verbal and written
- Strong organizational and leadership skills
- Ability to maintain professional and positive attitude
Travel: 0-50% (can be adjusted)
Lifting: 0-50 lbs. (can be adjusted)
Other: Computer work for long periods of time
THIS JOB DESCRIPTION SHOULD NOT BE DEEMED ALL-INCLUSIVE. ADDITIONAL REQUIREMENTS AND EXPECTATIONS MAY BE ASSIGNED. AT ALL TIMES, EMPLOYEES ARE EXPECTED TO ADHERE TO COMPANY POLICIES AND COMPANY SOPS.
Qinecsa is an equal opportunity employer. Qinecsa evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.