Associate Medical Director

11 hours ago

Pune, India PrimeVigilance Full time
Job Description

The Associate Medical Director needs to work with the Head of Medical Operations/Medical Director on the following:

• Assignment of the PV physicians to client projects

• Ensuring adequate and appropriately qualified physician resources across client projects

• Ensuring quality, compliance and efficiency for physician activities within a Client project

• Ensuring the integration, analysis and interpretation of safety information collected from preclinical through to post-marketing, including medical review of individual case safety reports, signal detection and validation, aggregate report review and risk/benefit analysis

• Providing expert safety input to the clinical development program for some client projects while giving expert medical input to clinical trials

• Maintaining good client relations and ensuring a consistently high quality of work for each client

• Attending regular client meetings to present/discuss safety data received/reviewed

• Ensuring that Investigator’s Brochures, Clinical Study Protocols and Study Safety Plans/Joint. Operating Procedures include a formal check of all areas related to PV Physician related activities as outlined in the client contract.

• Reviewing or drafting responses to requests on all drug safety matters from Competent

Involvement in the development/review of Risk Management Plans/

Periodic Safety Update reports/Developmental Safety Update Reports and other aggregate/ad

hoc reports for client company products.

• Actively participating in the Drug Safety Review Committee - signal detection and risk evaluation

• process for Client company medicinal products in the product’s life cycle.

• Overseeing and managing a group of pharmacovigilance physicians and would be responsible for the quality, compliance and timeliness of their work

• Support the Head of Medical Operations/Medical Director in quality and efficiency strategies

• Create strategy for the team, ensuring adherence by contributors via oversight of metrics reports. Oversee key performance indicators of deliverables prepared by key stakeholders, e.g., Clients, compliance team, quality team

• Supporting and overseeing development of risk-based assessments and mitigation plans and its execution within medical department

• Ensuring appropriate escalation of potential quality issues to the Head of Medical Operations/Medical Director and its follow up till resolution

• Support the Business/Commercial team in pharmacovigilance medical aspects of the development of contracts and proposals

• Support the Head of Medical Operations/Medical Director by attending bid defense meetings and conferences as the medical expert, as required

• Delivering PV medical training presentations and PV medical training as required

• Can act as EEA QPPV and/or Deputy for up to 2 clients if required.

• Participates in the training of Prime Vigilance physicians and is responsible for maintaining and developing their level of professional interest and expertise.


Qualifications

The Associate Medical Director should be medically qualified as a physician; ideally a higher qualification also or a postgraduate qualification relevant to pharmacovigilance or pharmacoepidemiology



Additional Information

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.    

To succeed we must work together with a human first approach. Why? Because our people are our greatest strength leading to our continued success on improving the lives of those around us.   

  We offer:   

  • Training and career development opportunities internally    
  • Strong emphasis on personal and professional growth   
  • Friendly, supportive working environment   
  • Opportunity to work with colleagues based all over the world, with English as the company language   

Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join    

  • Quality   
  • Integrity & Trust    
  • Drive & Passion    
  • Agility & Responsiveness    
  • Belonging   
  • Collaborative Partnerships    

Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application

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