Scientific Manager (Pharmacovigilance & Medical Affairs)

2 - 5 Years
Bengaluru

Job Description

Scientific Manager (Pharmacovigilance & Medical Affairs)


The Scientific Manager is responsible for the day-to-day activities related to safety (pharmacovigilance) of the products (Both in clinical development & marketed).This person is knowledgeable regarding regulatory requirements & project management pertaining to pharmacovigilance. 

Scientific Manager would also handle all scientific queries related to marketed products of Himalaya.

Overview of the role & responsibility:

To develop the system, process and modus operandi of Global Pharmacovigilance Cell for Unified Pharmacovigilance System at Himalaya, to have a robust, well structured, process driven PV system across regions (global level). 
Functions as 
Pharmacovigilance Coordinator for Global Pharmacovigilance Cell to coordinate with respective HUB across globe.

To develop the procedures, SOPs, guidelines and other standard materials required for PV compliance in accordance with applicable regulatory guideline of the various geography.

Evaluates & assess the drug safety software tool in collaboration with IT team to organize and process the PV system to cater the global need of Himalaya. Coordination for safety related activities with 24/7 medical & safety cell of the organization.

SAE management optimization, Pharmacovigilance operations management, review of performance of existing drug safety activities. Organize and ensure timely reporting of SAEs. Write and/ or review SAE narratives and CIOMS Forms for the reported events.

Directs and oversees activities for a project which may include but is not limited to individual case safety reports, aggregate reporting, medical information response fulfilment, risk management plans. 

Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements. 

Assess Lifecycle Safety data report to relevant authorities in a format compatible to requirement.

Oversee the activities of team related to safety aspect of all the Himalaya products and Imparts/ arrange safety trainings to study team & marketing team. Manage safety analyses and signal detection activities and contribute to the Reference Safety 

Information and Safety Communications. 

Contribute to and provide medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event reports received for Himalaya products.

Liaise with different functional team members, e.g. project management, clinical, data management; health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related safety issues. 
Serving as a link between company and the patients or healthcare experts to provide scientific validated information on product safety.

Develops the Safety Management Plan for the new clinical studies. 
Contribute and provide review on safety sections for protocols other clinical trial related documents. 

Supports the Clinical Operations teams with respect to safety related issues as required and oversees reconciliation of clinical and safety databases. 
Management of Pharmacovigilance System Master File (PSMF).

Assist audits/inspections of systems and procedures to ensure quality, integrity and compliance with pharmacovigilance and safety reporting. Response to regulatory findings relevant to safety operations and processes.

Support in medical affairs activities related to Himalaya products. 

Provide support to marketing team for responding scientifically to the medical queries raised by the Doctors/ Field staff.

Skill Requirements:
Working knowledge of global PV requirements (e.g. ICH E6, ICH E2A, ICH E2B, CFR, WHO)

Working experience of globally accepted and validated safety databases

Knowledge of WHO-DD & MedDRA terminology and its application.

Basic knowledge of clinical trial concepts including ICH-GCP

Extensive knowledge and comfort of searching the scientific material available on open resources.

Ability to communicate scientific or medical information in a clear and concise manner. In order to be effective in job, candidate must have aptitude to be aware of current industry practices and regulatory requirements that would cater the need with regards to medical affairs activities.

Role Requirements:
Degree in modern medicine (MBBS) and/ or MD with approximate 2-3 years of experience in Pharmacovigilance is must for the position.

Salary: INR 15,00,000 - 20,00,000 P.A.

Industry:Pharma / Biotech / Clinical Research

Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:R&D

Role:Clinical Research Associate/Scientist

Employment Type:Permanent Job, Full Time

Keyskills

Desired Candidate Profile

Please refer to the Job description above

Education-

UG:MBBS - Medicine

PG:Medical-MS/MD - Any Specialization

Company Profile

The Himalaya Drug Company

Working in Himalayas means to learn and grow continuously.Opportunities to work on the finest ever products in the herbal space, competitive salaries and excellent benefits. We offer challenging assignments, a world class working environment, professional management and ample prospects to train and learn along with exceptional rewards.
View Contact Details+

Recruiter Name:HR TEAM

Contact Company:The Himalaya Drug Company