Lambda Therapeutic Research is a renowned global organization offering a wide range of services in the field of pharmacovigilance, clinical trials, and medical research. They are known for their commitment to providing high-quality solutions in drug safety and helping to ensure compliance with international safety standards. Lambda Therapeutic Research offers excellent opportunities for career growth and development, making it an ideal workplace for professionals in the pharmaceutical industry.
Responsibilities in the Job: As an Officer in Pharmacovigilance at Lambda Therapeutic Research, your job responsibilities will include a wide range of tasks related to drug safety and regulatory compliance. These responsibilities are key to ensuring the safe use of pharmaceutical products and maintaining the integrity of safety data. Your tasks will include:
- Literature Screening: Review worldwide scientific and medical literature in accordance with company-controlled documents and relevant regulations.
- Safety Case Management: Enter and manage safety reports, ensuring timely data entry, drug coding, MedDRA coding, causality assessment, and narrative writing of Individual Case Safety Reports (ICSR).
- Case Processing: Handle case processing tasks, including duplicate searches, managing tracking of all cases from regulatory authorities, and performing weekly reconciliations.
- Regulatory Compliance: Support the group leader in timely submissions and ensure compliance with global pharmacovigilance requirements and local regulations.
- Medical Inquiries: Handle and track adverse event/product complaints through various channels (email, phone, fax) and communicate responses in collaboration with the medical reviewer.
- Training and Documentation: Provide training to new team members, and assist in the preparation and revision of SOPs, WI, templates, and guidance documents.
Qualifications: To qualify for this role, you should possess the following qualifications:
- Education: M.Pharm or Pharm D (Master’s in Pharmacy or Doctor of Pharmacy).
- Experience: 0 to 2 years of experience in pharmacovigilance or related fields.
This role provides an excellent opportunity for fresh graduates or individuals with limited experience in pharmacovigilance, offering both training and professional development.
Skills: The ideal candidate should have the following skills:
- Strong understanding of pharmacovigilance principles and regulatory requirements.
- Knowledge of MedDRA coding, ICSR preparation, and drug coding.
- Excellent communication skills for handling medical inquiries and collaborating with internal teams.
- Attention to detail and the ability to manage multiple tasks effectively.
- Proficiency in using safety databases and software.
- Ability to work in a team and support various aspects of pharmacovigilance operations.
