Pharmacovigilance Manager
6 months ago
PATH current employees - please log in and apply
PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing heath challenges.
PATH’s CVIA conducts research, clinical development, introduction, and post-marketing activities for vaccines in the following disease areas: malaria, diarrheal diseases, polio, respiratory tract infections, meningitis, HPV and vector-borne viral diseases. CVIA’s goals are prove the safety and efficacy of selected vaccine candidates in phase 1-4 clinical trials, support their introduction into public health systems and evaluate their effectiveness and safety as they are introduced. In these endeavors, CVIA works closely with international vaccine manufacturers from early development through post-marketing effectiveness and pharmacovigilance (PV) surveillance activities. CVIA works in alignment with the programs and initiatives of WHO and its funders to efficiently expedite the application of life-saving vaccines across low- and lower middle-income countries (LMICs).
The Pharmacovigilance Group in CVIA Clinical team, where the Pharmacovigilance Manager position resides, works closely with other CVIA programs (Regulatory; CMC; and Policy, Access, and Introduction [PAI]), funders and partners in the regulatory submission, post-licensure evaluation of vaccine products and their initial adoption in LMICs. The incumbent will support CVIA and its international partners in setting up, implementing, and overseeing post-authorization vaccine pharmacovigilance activities to assess the risk / benefit of new vaccines. Specifically, the incumbent will provide inputs in: Establishing and strengthening pharmacovigilance capabilities of vaccine manufacturers based in LMICs.
Monitoring the risk/benefit of vaccines newly introduced into the public health programs of LMICs.
Developing training programs on pharmacovigilance topics for vaccine manufacturers based in LMICs.
The position reports to the Lead, Pharmacovigilance.
RESPONSIBILITIES:
Work with and otherwise coordinate with vaccine manufacturers to provide sustained technical support to maintain and further develop competencies related to pharmacovigilance. Actively interact with company and conduct regular meetings and updates to ensure smooth implementation. Actively participate in gap analysis of current PV system and provide inputs for systems development to address the gaps. Create SOPs, SOP templates and other PV tools under guidance. Develops training materials for LMIC public health agencies, and vaccine manufacturers, and participates in pharmacovigilance training programs in conjunction with other CVIA staff. Impart trainings. Drafts responses to pharmacovigilance requests from regulatory agencies. Present technical updates and represent PATH at scientific, global health and major national and international meetings. Facilitate communication and participate in collaborative efforts related to pharmacovigilance with all PATH vaccine program staff, partners, collaborators, and funders, including industry, academia, government agencies, multilateral health organizations and non-governmental organizations. Adhere to timelines provided and proactively identify and escalate risks in a timely fashion. Oversee adherence to Good Clinical Practices, human subject research protection, local and international regulations, and protocol-specific procedures applied to CVIA’s pharmacovigilance efforts. Keep abreast of new developments in pharmacovigilance practices and requirements from regulatory and other health authorities (e.g., WHO); maintain current knowledge of and anticipate changes in the landscape of vaccine pharmacovigilance. Maintain awareness of medical / scientific literature related to the risk/benefit of vaccines.REQUIRED SKILLS
M.D. or other equivalent doctorate degree in related scientific discipline with 10 or more years of experience in supporting post—authorization pharmacovigilance activities at increasingly responsibility levels and in different capacities in pharmaceutical or vaccine (preferrable) industry. Extensive knowledge of pharmacovigilance requirements by USFDA, EMA, and other international normative and regulatory agencies. Experience in routine PV activities like periodic safety update report writing, signal detection activities, medical review of individual case safety reports. Hands-on experience in PV safety database operations. Knowledge and understanding of clinical development, clinical trial standards, and safety data analyses. Articulate communicator, excellent written and verbal communication skills (English language essential), with strong interpersonal and presentation skills. Self-motivated, with leadership abilities. Strong analytical, and problem-solving skills. Ability to work in a small team in a global environment. Open, engaging, and transparent work style with a global perspective and mindset; ability to work effectively with colleagues from myriad of cultures, backgrounds, and geographies. Ability to travel up to 20%. Desirable: Experience in developing / implementing / overseeing public health programs related to safety evaluations of new vaccines. Desirable: Knowledge of vaccine pre-qualification requirements of the WHO.Location: New Delhi
-
Pharmacovigilance Manager
4 weeks ago
Delhi, Delhi, India PATH Full timeJob Title: Pharmacovigilance ManagerPATH is seeking a highly skilled Pharmacovigilance Manager to join our team in New Delhi. As a key member of our Clinical team, you will play a critical role in supporting the development and implementation of pharmacovigilance strategies for vaccines in low- and lower-middle-income countries.Key Responsibilities:Develop...
-
Pharmacovigilance Manager
4 weeks ago
Delhi, Delhi, India PATH Full timeJob Title: Pharmacovigilance ManagerPATH is seeking a highly skilled Pharmacovigilance Manager to join our team in New Delhi. As a key member of our Clinical team, you will play a critical role in ensuring the safety and efficacy of vaccines in low- and lower middle-income countries.Key Responsibilities:Provide technical support to vaccine manufacturers to...
-
Pharmacovigilance Specialist
2 weeks ago
Delhi, Delhi, India PATH Full timeAbout the RoleThe Pharmacovigilance Manager will play a key role in supporting PATH's vaccine programs by providing technical expertise and guidance on pharmacovigilance activities.Key ResponsibilitiesWork with vaccine manufacturers to provide technical support and maintain pharmacovigilance competencies.Participate in gap analysis and provide inputs for...
-
Pharmacovigilance Manager
1 week ago
Delhi, Delhi, India PATH Full timeAbout PATHPATH is a global nonprofit dedicated to achieving health equity. With over 40 years of experience forging multisector partnerships and expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world's most pressing health challenges.About the PositionJob...
-
Corporate Quality Assurance Associate
5 months ago
New Delhi, India Soterius Full timeLooking for a great career at a cutting edge service provider to pharmaceutical companies and regulatory authorities? Soterius is looking for talented go-getters who are committed to our values of excellence and uncompromising quality. **Job Location**: New Delhi, India**: **Requirements**: - At least 2 years of experience in quality assurance in GCP,...
-
Medical Reviewers/safety Physician
5 months ago
New Delhi, India Soterius Full timeLooking for a great career at a cutting edge service provider to pharmaceutical companies and regulatory authorities? Soterius is looking for talented go-getters who are committed to our values of excellence and uncompromising quality. **Job Location**: New Delhi, India**: **Requirements**: - MBBS/MD from an MCI approved institute - 0-3 years of experience...
-
Drug Safety Physician
6 days ago
delhi, India Biocon Biologics Full timeWe are seeking a drug physician in Biocon Biologics Pharmacovigilance who independently or in association with senior physicians will be responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk...
-
Drug Safety Physician
6 days ago
Delhi, India Biocon Biologics Full timeWe are seeking a drug physician in Biocon Biologics Pharmacovigilance who independently or in association with senior physicians will be responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk...
-
Drug safety physician
5 days ago
Delhi, India Biocon Biologics Full timeWe are seeking a drug physician in Biocon Biologics Pharmacovigilance who independently or in association with senior physicians will be responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk...
-
▷ (15h Left) Drug Safety Physician
6 days ago
Delhi, India Biocon Biologics Full timeWe are seeking a drug physician in Biocon Biologics Pharmacovigilance who independently or in association with senior physicians will be responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk...
-
Drug Safety Physician
6 days ago
delhi, India Biocon Biologics Full timeWe are seeking a drug physician in Biocon Biologics Pharmacovigilance who independently or in association with senior physicians will be responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk...
-
Drug Safety Associate
5 months ago
New Delhi, India Fusion Technology Solutions Full timeThe main role of a Drug Safety Associate is to monitor the safety of drugs and medical devices once they are on the market and ensure that they are being used safely. - Reviewing and evaluating adverse event reports (AERs) to determine if they meet regulatory reporting requirements. - Entering and maintaining adverse event information in safety databases -...
-
Therapy Business Manager || GI Optima || Gurgaon
4 weeks ago
New Delhi, India Abbott Full timeTerritory Business Planning: Plan for the monthly and quarterly business. Plan demand generation and fulfillment Monitor actual Sales and mid-course corrections and inputs to reduce variance against expectations Prescription audit for Abbott brands and other competitors brands To create and update customer list having specified number of doctors...
-
Clinical Medical Manager
2 months ago
New Delhi, India Novo Nordisk Full timeThe position As a Clinical Medical Manager, you will be responsible for : Facilitate the execution of clinical trials related to New Therapy Areas (including CVD, CKD, NASH) by providing medical/scientific expertise and advice. Identify and map KOLs, investigators, and research centres within the relevant therapy areas. Collect early scientific...
-
Therapy Business Manager
3 weeks ago
Delhi, Delhi, India Abbott Full timeTerritory Business Planning:Develop and execute monthly and quarterly business plans to drive sales growth.Plan demand generation and fulfillment strategies to meet customer needs.Monitor actual sales performance and make mid-course corrections to reduce variance against expectations.Conduct prescription audits for Abbott brands and competitors.Create and...
-
Therapy Business Manager
3 weeks ago
Delhi, Delhi, India Abbott Full timeTerritory Business Planning:Develop and execute monthly and quarterly business plans to drive sales growth.Plan demand generation and fulfillment strategies to meet customer needs.Monitor actual sales performance and make mid-course corrections to reduce variance against expectations.Conduct prescription audits for Abbott brands and competitors' brands to...
-
Therapy Business Development Manager
3 weeks ago
Delhi, Delhi, India Abbott Full timeTerritory Business Planning:Develop and execute monthly and quarterly business plans to drive sales growth.Plan demand generation and fulfillment strategies to meet customer needs.Monitor actual sales and make mid-course corrections to reduce variance against expectations.Conduct prescription audits for Abbott brands and competitors' brands.Create and...
-
Sales Manager
3 weeks ago
New Delhi, India YD Talent Solutions Full timeThis is a remote position.Sales ManagerHealthTechIndiaAbout our client:Our client is a leading global clinical trial company renowned for its awardwinning solutions that drive innovation and excellence in clinical research. They implement cutting edge technologies like AI/ML and GenAI to accelerate clinical trials for better outcomes. Their unparalleled...
-
Therapy Business Development Manager
3 weeks ago
Delhi, Delhi, India Abbott Full timeTerritory Business Planning:Develop and execute monthly and quarterly business plans to drive sales growth.Plan demand generation and fulfillment strategies to meet customer needs.Monitor actual sales performance and make mid-course corrections to reduce variance against expectations.Conduct prescription audits for Abbott brands and competitors to identify...
-
Sales Manager
1 month ago
New Delhi, India YD Talent Solutions Full timeThis is a remoteposition.Sales ManagerHealthTechIndiaAboutourclient:Ourclient is a leading global clinical trial company renowned for itsawardwinning solutions that drive innovation and excellence inclinical research. They implement cutting edge technologies likeAI/ML and GenAI to accelerate clinical trials for better outcomes.Their unparalleled expertise...
