Job Opportunity for Senior Manager – Pharmacovigilance at PATH in New Delhi, India

**Job Title:** Senior Manager – Pharmacovigilance  

**Location:** New Delhi, India  

**Experience Required:**  

– **Education:** M.D. (Doctor of Medicine) or other equivalent medical degree, or doctorate degree in a related scientific discipline.  

– **Experience:** 12 or more years of experience in supporting post-authorization pharmacovigilance activities at increasingly responsible levels and in different capacities in the pharmaceutical or vaccine industry (preferably).  

**Key Skills:**  

– Extensive knowledge of pharmacovigilance requirements by regulatory agencies such as USFDA, EMA, and others.  

– Hands-on experience in routine PV activities like periodic safety update report writing, signal detection, medical review of individual case safety reports, and PV safety database operations.  

– Knowledge of clinical development, clinical trial standards, and safety data analysis.  

– Excellent written and verbal communication skills in English.  

– Strong interpersonal, analytical, and problem-solving abilities.  

– Ability to work effectively in a global environment with colleagues from diverse cultures and backgrounds.  

**About Us:**  

PATH is a global nonprofit dedicated to achieving health equity. With over 40 years of experience, PATH forges multisector partnerships and develops innovative solutions to address pressing health challenges. The Center for Vaccine Innovation and Access (CVIA) focuses on research, clinical development, introduction, and post-marketing activities for vaccines in areas such as malaria, diarrheal diseases, polio, respiratory tract infections, meningitis, HPV, and vector-borne viral diseases. CVIA works closely with international vaccine manufacturers and aligns with WHO and funders to expedite life-saving vaccines into low- and lower middle-income countries (LMICs).  

**Key Responsibilities:**  

1. Provide technical support to establish and strengthen pharmacovigilance capabilities of vaccine manufacturers in LMICs.  

2. Monitor the risk/benefit of vaccines introduced into public health programs in LMICs.  

3. Develop training materials and conduct training programs on pharmacovigilance for manufacturers, public health agencies, and PATH staff.  

4. Draft responses to pharmacovigilance requests from regulatory agencies.  

5. Represent PATH at scientific meetings and collaborate with global health partners.  

6. Oversee adherence to Good Clinical Practices and local/international regulations.  

7. Stay updated on new developments in pharmacovigilance practices and medical literature related to vaccine safety and efficacy.  

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