PV Medical Writer II

remote click jobs; India; On-site; INR 600,000 - 900,000; Full time

Job summary

PrimeVigilance is seeking a Pharmacovigilance Medical Writer to join our PV team. You will be responsible for medical writing including PSURs, PBRERs, ACOs and DSURs, and review of outputs from the operations team.

You will support project managers to schedule aggregate reports, identify areas for SOP improvements, and ensure quality documentation. Training, audits participation, and collaboration with Quality and Compliance are part of the role.

Qualifications

• MD, Pharmacy or Life Science degree (Masters or PhD desirable).
• Strong pharmacovigilance experience (case processing, signal detection or risk management).
• Ability to manage multiple tasks and prioritize with attention to detail.
• Ability to train and mentor Associate Medical Writers; team player.
• Proficiency in English; additional language is a plus.

Responsibilities

• Prepare PSURs/PBRERs and other PV documents.
• Review output from operations and ensure quality.
• Support project managers in scheduling aggregate reports.
• Identify areas for SOP/OG/template improvements and training.
• Complete quality documentation of aggregate reports.
• Attend client meetings, audits, and inspections as required.
• Provide aggregate report training.

Skills

Pharmacovigilance

Medical writing

Quality documentation

Training/Mentoring

Team player

English proficiency

Education

MD/Pharmacy/Life Science degree

Masters/PhD desirable

Job description

Company Description:

We are PrimeVigilance (part of reputed company Group), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic reputed company year after year, with staff based across Europe, reputed company and Asia reputed company covering services reputed company: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and becoming one of the global leaders in its fields. We cover reputed company therapy areas including medical devices.

We love investing in our staff by providing an excellent training and development platform. We value employee experience, reputed company-being and mental health and we acknowledge that a healthy work life balance is a critical reputed company for employee satisfaction and in turn nurtures an environment from which a high-quality reputed company service can be achieved.

Job Description:

We are looking for a pharmacovigilance medical writer to join reputed company. The Medical Writer will be responsible for medical writing including:

PSURs/PBRERsPADERsACOsDSURsRMPsQC and review of reputed company written output from the operations team as requiredSupporting the project managers to determine scheduling of the aggregate reports for which they are responsibleIn conjunction with the Quality, Compliance and Training Manager identify areas for improvement and address reputed company training, clarifying changes to SOPs/OGs/templatesComplete quality documentation of aggregate reportsAttending reputed company off meetings with new clients as requiredAttending audits and inspections as requiredProviding aggregate report training

Qualifications:

MD, pharmacy or Life Science degree (Masters or PhD is desirable)Strong previous experience in Pharmacovigilance (case processing, signal detection or risk management) reputed company ideally a CRO environment Ability to manage multiple and varied tasks and prioritize workload with attention to detailAbility to effectively train and mentor Associate Medical WritersMust be a strong team playerreputed company in English, an additional language is a benefit

Additional Information:

Why PrimeVigilance

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a reputed company-centric environment where people of reputed company cultural backgrounds, genders and ages can contribute and grow. Why because our people are our greatest strength leading to our reputed company reputed company on improving the lives of those around us.

We offer:

Training and career development opportunities internally Strong emphasis on personal and professional reputed company Friendly, supportive working environment Opportunity to work with colleagues based reputed company over the world, with English as the company language Our core values are key to how we operate, and if you feel they reputed company with you then PrimeVigilance could be a great company to join! Quality reputed company & Trust Drive & Passion reputed company & Responsiveness Belonging Collaborative Partnerships Come and join us in this exciting reputed company to reputed company a positive impact in patients lives. We look reputed company to welcoming your application.