Manager- Pharmacovigilance
by Medreich Limited in Bengaluru/Bangalore
Experience: 4 to 7 yrs. | Opening(s): 1 Posted on: 20 Sep
Job Description
To provide proactive safety surveillance across the lifecycle of Medreich products, and Support development and execution of risk management plans, risk assessment, and risk communications while complying with legal/regulatory requirements concerning adverse event monitoring and reporting.
To ensure Adverse Event reports are processed in an accurate and timely fashion in accordance with regulatory requirements.
Handling medical information enquiries from both in-house and external customers, and management of Frequently Asked Questions
To be responsible for processing of incoming adverse event reports and reporting to regulatory authorities, with the objective of achieving a high level of regulatory compliance.
To ensure that all Pharmacovigilance activities are conducted in accordance with SOP's, Medreich Work Instructions, Good Clinical Practice guidelines and regulatory requirements.
Preparation and maintenance of Pharmacovigilance documentation and SOPs.
Coordinate for any internal audits or external inspections in different locations
To coordinate for Periodic Safety Update Reports.
To liaise with Clinical Research personnel in the preparation of safety data required in support of the clinical research programme.
Conduct safety data analysis in support of developing and updating safety sections of regulatory documents, informed consent, annual reports, company core data sheets, product labels, etc.
To respond to all medical and technical enquiries accurately and in accordance with current opinion/knowledge, the published literature and Medreich in-house expertise.
To develop a database of frequently asked Questions,
Contact with all members of the internal teams including Regulatory Affairs, Quality Control, Quality Assurance, and Sales & Marketing Etc.
Excellent interpersonal skills in developing effective relationships with safety data customers and colleagues, with the ability to communicate with diverse individuals and groups
Proficiency in the processing, assessment of safety data
Demonstrated computer literacy, with proficiency in the used and management of safety Databases, Window, Excel, etc.
Previous experience with adverse event reporting systems, EU /UK drug safety/Pharmacovigilance requirements
To ensure Adverse Event reports are processed in an accurate and timely fashion in accordance with regulatory requirements.
Handling medical information enquiries from both in-house and external customers, and management of Frequently Asked Questions
To be responsible for processing of incoming adverse event reports and reporting to regulatory authorities, with the objective of achieving a high level of regulatory compliance.
To ensure that all Pharmacovigilance activities are conducted in accordance with SOP's, Medreich Work Instructions, Good Clinical Practice guidelines and regulatory requirements.
Preparation and maintenance of Pharmacovigilance documentation and SOPs.
Coordinate for any internal audits or external inspections in different locations
To coordinate for Periodic Safety Update Reports.
To liaise with Clinical Research personnel in the preparation of safety data required in support of the clinical research programme.
Conduct safety data analysis in support of developing and updating safety sections of regulatory documents, informed consent, annual reports, company core data sheets, product labels, etc.
To respond to all medical and technical enquiries accurately and in accordance with current opinion/knowledge, the published literature and Medreich in-house expertise.
To develop a database of frequently asked Questions,
Contact with all members of the internal teams including Regulatory Affairs, Quality Control, Quality Assurance, and Sales & Marketing Etc.
Excellent interpersonal skills in developing effective relationships with safety data customers and colleagues, with the ability to communicate with diverse individuals and groups
Proficiency in the processing, assessment of safety data
Demonstrated computer literacy, with proficiency in the used and management of safety Databases, Window, Excel, etc.
Previous experience with adverse event reporting systems, EU /UK drug safety/Pharmacovigilance requirements
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Medical Professional
Role: Medical Officer
Desired Candidate Profile
Education:
Please refer to the Job description above UG - MBBS - Medicine
PG - M.S/M.D - Any Specialization, Post Graduation Not Required
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
PG - M.S/M.D - Any Specialization, Post Graduation Not Required
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Company Profile
Medreich is a pharmaceutical company that has been in existence since 1976, manufacturing generic and branded drugs in several therapeutic areas. In 1994 a strategic joint venture with Medreich plc of UK put the company firmly in the global arena. With more than 2500 employees worldwide, exceptional quality standards and a client base that is spread across 54 countries, Medreich has built a reputation for raising the bar on product superiority with every undertaking.
Medreich"s R&D and manufacturing facilities have received the seal of approval from leading global regulatory bodies such as -UK MHRA, Australia TGA, SA MCC, Health Canada, French FDA. The company produces drugs for leading, global pharmaceutical companies such as GSK, Pfizer, Sanofi Aventis, Wyeth, Merck, among others.
Medreich"s R&D and manufacturing facilities have received the seal of approval from leading global regulatory bodies such as -UK MHRA, Australia TGA, SA MCC, Health Canada, French FDA. The company produces drugs for leading, global pharmaceutical companies such as GSK, Pfizer, Sanofi Aventis, Wyeth, Merck, among others.
Contact Details
Recruiter Name:Aravinda P
Contact Company:Medreich Limited
Address: Medreich ltd No 12/8 Medreich House Saraswati Ammal street, Maruthi seva nagar, BANGALORE,Karnataka,India
Telephone:91-80-25493334
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