Senior Drug Safety Associate - Medical Information Call Centre

Location

India | India

Job description

Senior Drug Safety Associate MICC is a safety professional responsible for assessing the safety of pharmaceutical drugs undergoing clinical trials or once they are in the market. Using standard guidelines, they determine whether the medication causes any adverse reactions in patients and report their findings back to regulatory bodies and health authorities.

The individual will be an integral part of a group of safety professionals within Sitero and will closely collaborate with safety teams in Contract Research Organizations (CROs) and partners. He/she will need to maintain medical knowledge as required by the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Experience in managing calls from patients across US, Canada and Europe
• Competency with medical and therapeutic terminology
• Able to perform calls for follow up queries, discuss about product information as needed
• Understand the requirements of callers and provide precise information
• Manage product specific inquiries/medical inquires , product complaints, AE/SAE calls as needed
• Perform case processing and medical coding of ICSR s as needed
• Responsible for performing end to end case processing of Individual case safety reports to meet regulatory timelines
• Contributes to safety and pharmacovigilance training programs.
• Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community.
• Serves as a subject matter expert for vendors providing drug safety and pharmacovigilance services.
• Training and mentoring of Pharmacovigilance Associates on MICC as needed

EDUCATION AND EXPERIENCE REQUIRED:

• Minimum 2+ year of experience in drug safety as a part of Medical Information Call Centre Team (MICC)
• Fluent in FRENCH language
• Degree in Life Science/Pharma or Equivalents

PREFERRED SKILLS:

• 2-4 year of experience in drug safety, MICC
• Proficient in English and French
• Awareness of Safety database, Scientific coding browser: MedDRA, WHO etc
• In depth Knowledge and understanding of Drug Safety/Pharmacovigilance regulations with respect to pharmaceutical drugs and other related products
• Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited and post-marketing environment).
• Ability to build relationships, collaborate and influence across disciplines within Sitero and with outside stakeholders.
• Excellent verbal, written and presentation skills.
• Innovative, collaborative, initiative-taker.

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Salary