Pharmacovigilance jobs for Pharmacy Candidates at Akums Drugs & Pharmaceuticals Limited

Akums Drugs & Pharmaceuticals Limited Vacancy in Pharmacovigilance (PV) for Individual Case Safety Reports (ICSR) Processing Expert. For B pharm, M pharm and Pharma D Candidates

We have vacancy in Pharmacovigilance (PV) for Individual Case Safety Reports (ICSR) Processing Expert at Akums drugs and pharmaceuticals at Haridwar location.

Post Name: Individual Case Safety Reports (ICSR) Processing Expert

Responsibilities include, but are not limited to: Responsible for global and local literature surveillance. Responsible for ICSR management and submission to applicable regulatory authority.

Responsible for effective compliance of ICSR systems. Responsible for preparation, review and implementation of Standard Operating Procedures/Work Instructions.

Responsible for tracking and validating each and every sources of market complaints

Responsible for duplicate check of the existing cases Responsible for coordinating with different departments on an urgent basis related to Pharmacovigilance activities & Regulatory queries.

To provide the expert comments in process of reference safety information updates.

Minimum requirements

Educational Qualification : B Pharmacy / M. Pharm / Pharm. D or equivalent with 2-3 years relevant work experience OR equivalent combination of education, training and experience.

In depth knowledge and understanding of applicable global, regional, local regulatory requirements i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPS.

Proven ability to meet strict deadlines.

Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint).

Candidate who can join immediately will be given preference.

Application Process : Please share CV at below mentioned email id. priyanka.das@akums.in gobindsingh.hr@akums.in

Vacancy in Pharmacovigilance (PV) compliance and Quality Associate

We have vacancy in Pharmacovigilance (PV) for PV compliance and Quality Associate at Akums drugs and pharmaceuticals at Haridwar location.

Post Name: PV compliance and Quality Associate:

Responsibilities include, but are not limited to:

Develop and implement quality and compliance metrics for new safety case management and aggregate reporting processes, working with the process/metrics owners, Quality Assurance (QA) and other global line functions as appropriate.

• Lead projects to optimize methodologies and processes used to monitor safety cases and aggregate reports quality as well as internal and regulatory compliance:
• Develop and maintain tools in collaboration with Innovation, Tech & Systems and other Global Line Functions to assist in the monitoring of quality and compliance, introducing automation where possible.
• Maintain procedural documents including manuals. Develop and implement training material and communications Assess the impact of any changes to worldwide regulations and update as required in order to ensure continued suitability.
• Lead investigations in to any deficiencies identified, develop and implement corrective and preventative actions (CAPAS) and measuring the effectiveness of these.

Act as a subject matter expert during audits and inspections (e.g. CDSCO, FDA and EMA), lead the preparation of responses to findings and the development and implementation of CAPAS.

• Collaborate with other Global Line Functions across Akums Divisions, including Patient Safety Alliance, medical affairs and marketing to ensure implementation of CAPAS and fulfilment of the safety requirements.

Minimum requirements

Educational Qualification: B. Pharm/M. Pharm/PharmD/ MSc degree in life sciences or equivalent. Fluency in English.

• Minimum 5 to 7 years of experience in the pharmaceutical industry, particularly in Pharmacovigilance

• In depth knowledge and understanding of applicable global, regional, local regulatory requirements i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization
(ICH) guidelines, SOPs.

Strong negotiation, presentation and communication skills, and ability to operate effectively in an international environment and across functions

• Strong analytical skills, Quality focus and ability to mentor and coach

Vacancy in Pharmacovigilance (PV) Safety Data Exchange Agreement (SDEA) Management Associate

We have vacancy in Pharmacovigilance (PV) for Safety Data Exchange Agreement (SDEA) Management Associate at Akums drugs and pharmaceuticals at Haridwar location.

Post Name: Pharmacovigilance (PV) Safety Data Exchange Agreement (SDEA) Management Associate

Responsibilities include, but are not limited to:

Responsible for development and maintenance of PV Safety Data Exchange Agreement (SDEA) of different clients.

Responsible for effective compliance of PV system in respect to SDEA Management.

Responsible for coordinating with different stakeholders on an urgent basis related to Pharmacovigilance activities & queries.

To do the monthly reconciliation with the Licensing Partners.

Responsible for identifying the importance of SDEA with different stakeholders. Responsible for identifying the gap among all SDEAS and
need for updating the SDEA.

To assist the internal and external audits/ inspections. To impart Pharmacovigilance training business partners related to PV procedures and regulatory obligations. To evaluate potential medically relevant information with market complaints.

Any other additional responsibility may be assigned from time to time by management.

Minimum requirements

Educational Qualification : B Pharm / M pharm /PharmD / MSc degree in life sciences or equivalent with 3-4 years relevant work experience OR equivalent combination of education, training and experience.

global, regional, local regulatory requirements i.e. Good Proven ability to meet strict deadlines.

In depth knowledge and understanding of applicable Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs.

Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Candidate who can join immediately will be given preference. Please share CV at below mentioned email id. priyanka.das@akums.in gobindsingh.hr@akums.in

Vacancy in Pharmacovigilance (PV) Safety Report Writing Specialist PBRERS/PSUR, DSURS, PADERS, RMPS, ACOS & Signal

We have vacancy in Pharmacovigilance (PV) for Safety Report Writing Specialist at Akums drugs and pharmaceuticals at Haridwar location.

Post Name: Safety Report Writing Specialist PBRERS/ PSUR, DSURS, RMPS, ACOS, Signal Safety Report Writing Specialist

Responsibilities include, but are not limited to:

Lead, author and finalize aggregate reports, including but not limited to PBRERS/PSUR, DSURS, PADERS, RMPS, ACOS, signal and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.

Conduct / Lead on-going literature safety surveillance for marketed and investigational products.

Assist with the identification of ICSRS from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management responsible person on post-marketing and clinical trial projects.

Author and/or QC review all types of signal management deliverables. Responsible for full documentation and tracking of signals.

In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.

Participate in internal and external audits and inspections, as required. Serve as the interface between the global project lead and the working team.

Minimum requirements

Educational Qualification : B. Pharm, M. Pharm, PharmD, or equivalent with 3 – 4 years relevant work experience OR equivalent combination of education, training and experience.

In depth knowledge and understanding of applicable global, regional, local regulatory requirements i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization
(ICH) guidelines, SOPs.

Proven ability to meet strict deadlines.

Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint).

Candidate who can join immediately will be given preference. Please share CV at below mentioned email id. priyanka.das@akums.in gobindsingh.hr@akums.in